<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261961</url>
  </required_header>
  <id_info>
    <org_study_id>E1203-R</org_study_id>
    <secondary_id>RX001203</secondary_id>
    <secondary_id>608119</secondary_id>
    <nct_id>NCT02261961</nct_id>
  </id_info>
  <brief_title>Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults</brief_title>
  <acronym>TDAP2</acronym>
  <official_title>Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The loss of muscle mass and strength due to aging leads to serious health problems for older&#xD;
      adults. Muscle health can be improved by exercise training, but some people improve their&#xD;
      strength substantially, whereas others improve little. The reason for this variation is&#xD;
      unknown. This study will investigate whether function of the immune system influences how&#xD;
      well people respond to exercise. Older Veterans who participate will have their muscle size,&#xD;
      strength, and function measured periodically for almost a year. Participants will drink a&#xD;
      nutritional supplement or placebo daily and complete a 36 session strength training program.&#xD;
      Participants will be vaccinated for tetanus and donate small amounts of blood and muscle&#xD;
      tissue during the study so that immune function can be compared to muscle outcomes during&#xD;
      training and during a long-term follow-up. The study results should increase the&#xD;
      investigators' understanding of the negative effects of aging on muscle and will possibly&#xD;
      lead to better strategies for muscle maintenance and rehabilitation for older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The study will examine the influence of immune function in older adults on&#xD;
      improvement of muscle mass, strength, and function by resistance training. The maintenance of&#xD;
      those benefits during long term follow-up will also be examined. This objective will be&#xD;
      accomplished by a double-blind randomized placebo-controlled trial of a nutritional&#xD;
      supplement (Muscle Armor) which evidence suggests can improve immune function, promote muscle&#xD;
      growth, and counteract muscle loss. The study premise is that aging results in decreased&#xD;
      ability of the immune system to respond to stimuli such as exercise. The study proposes that&#xD;
      the supplement will improve muscle health by promoting a shift in immune function of older&#xD;
      adults from a pro-inflammatory state towards a state which supports muscle growth and&#xD;
      maintenance.&#xD;
&#xD;
      Research Plan: The study will randomize Veterans (age 60-80, N=50) to participate in the&#xD;
      supplement or placebo groups in a three phase study. The phases of participation correspond&#xD;
      to the three specific aims. Aim 1 will determine if 2-weeks of supplementation improves&#xD;
      immune function. Humoral immune function will be assessed as the response to vaccination.&#xD;
      Innate immune function will be measured as systemic and cellular responses to acute&#xD;
      resistance exercise that the investigators' previous studies indicate are affected by aging.&#xD;
      Aim 2 will determine if supplementation during 36 sessions of progressive high-intensity&#xD;
      resistance training boosts improvement in muscle size (CT scan), strength, and function (gait&#xD;
      and balance). Muscle adaptations at the cellular levels will also be measured. Aim 3 will&#xD;
      determine if continued supplementation for 26-weeks after completion of exercise training&#xD;
      promotes the retention of the gains in muscle size, strength, and function. Multivariable&#xD;
      testing will then be used to compare the results between Aims 1, 2, and 3 to determine&#xD;
      whether or not immune function is correlated with muscle adaptation to training or&#xD;
      detraining.&#xD;
&#xD;
      Methods: Participants will undergo nine blood draws and five muscle biopsies of the vastus&#xD;
      lateralis over the course of the study so that the effects of the supplement on immune&#xD;
      function and cellular adaptations to training can be measured. Three of the blood draws will&#xD;
      be used to assess the antibody response to the tetanus, pertussis, and diphtheria vaccine.&#xD;
      Muscle and blood will be collected before and after a bout of exercise conducted before and&#xD;
      after the 2-weeks of supplementation prior to training. Immune function will be measured&#xD;
      using the blood based on pro- and anti-inflammatory cytokine levels, the balance between&#xD;
      specific T-cell subpopulations, and the proliferative capacity of mononuclear cells. Immune&#xD;
      function will be measured in muscle based on macrophage content of specific cytokines and&#xD;
      growth factors. The investigators' previous study showed that these muscle measures strongly&#xD;
      correlate with size and strength gain after training. Key signaling pathways including&#xD;
      nuclear factor-k B and PI3 kinase will also be measured. The fifth biopsy will be collected&#xD;
      post-training to measure adaptation at the cellular level based on changes in number of&#xD;
      satellite cells and myonuclei and fiber size. Hypotheses related to these measures will be&#xD;
      tested with 80% power to detect at least 0.8 standard deviations difference in means between&#xD;
      the supplement and placebo groups.&#xD;
&#xD;
      Clinical Relevance: Exercise is clearly able to affect immune function. However, the proposed&#xD;
      study will attempt to modulate immune function and determine the effects on exercise&#xD;
      outcomes. The study will also examine detraining, an important issue for older adults, that&#xD;
      is usually omitted from training studies. Thus, the study will potentially advance the&#xD;
      understanding of the mechanisms of muscle gain and loss in older adults, but more&#xD;
      importantly, the study will evaluate a nutritional intervention as a complement to exercise&#xD;
      for supporting muscle health during aging. Targeting the immune system may be the advantage&#xD;
      needed for an older Veteran to successfully maintain or restore the muscle mass, strength,&#xD;
      and function that is necessary for personal independence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2014</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)</measure>
    <time_frame>change from baseline at 1 week post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)</measure>
    <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Plasma Concentration of C-Reactive Protein</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Muscle Strength After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training phase (12 weeks)</time_frame>
    <description>The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)</measure>
    <time_frame>change from baseline at 1 week post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)</measure>
    <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)</measure>
    <time_frame>change from baseline at 1 week post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)</measure>
    <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
    <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Muscle Macrophages Per Myofiber (Resting)</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Size After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training phase (12 weeks)</time_frame>
    <description>The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Strength at Week 16 of the Post-Training Period</measure>
    <time_frame>difference between baseline and time point one of de-training follow-up period (week 16)</time_frame>
    <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period</measure>
    <time_frame>difference between time of training completion and time point two of de-training follow-up period (26 weeks)</time_frame>
    <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance at Week 16 of the Post-Training Period</measure>
    <time_frame>difference between time of training completion and time point one of de-training follow-up period (week 16)</time_frame>
    <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Ability After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Ability at Week 16 of the Post-Training Period</measure>
    <time_frame>difference between end of training and time point one of de-training follow-up period (week 16)</time_frame>
    <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Ability at Week 26 of the Post-Training Period</measure>
    <time_frame>difference between end of training and time point two of de-training follow-up period (week 26)</time_frame>
    <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Speed After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Speed at Week 16 of the Post-Training Period</measure>
    <time_frame>difference between after training and time point one of de-training follow-up period (week 16)</time_frame>
    <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Speed During at Week 26 of the Post-Training Period</measure>
    <time_frame>difference between after training and time point two of de-training follow-up period (week 26)</time_frame>
    <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Size at Week 26 of the Post-Training Period</measure>
    <time_frame>difference between baseline and time point two of de-training follow-up period (week 26)</time_frame>
    <description>The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up and Go After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up and Go at Week 16 of the Post-Training Period</measure>
    <time_frame>difference between after training and time point one of de-training follow-up period (week 16)</time_frame>
    <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up and Go at Week 26 of the Post-Training Period</measure>
    <time_frame>difference between after training and time point two of de-training follow-up period (week 26)</time_frame>
    <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Resting Muscle Concentration of Interleukin-1 Beta</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise)</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting Muscle Atrophy Gene MURF Expression</measure>
    <time_frame>percent change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise)</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting Muscle Protein Kinase B</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Protein Kinase B (Post-acute Exercise)</measure>
    <time_frame>change from baseline at 2 weeks of treatment</time_frame>
    <description>The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Myonuclei After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Fiber Size After Exercise Training for 12 Weeks</measure>
    <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
    <description>The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks</measure>
    <time_frame>at completion of the exercise training program (15 weeks)</time_frame>
    <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks</measure>
    <time_frame>completion of the exercise training program (15 weeks)</time_frame>
    <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks</measure>
    <time_frame>completion of the exercise training program (15 weeks)</time_frame>
    <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption</measure>
    <time_frame>end of study (42 weeks)</time_frame>
    <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption</measure>
    <time_frame>end of study (42 weeks)</time_frame>
    <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption</measure>
    <time_frame>end of study (42 weeks)</time_frame>
    <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Muscle Strength at Week 26 of the Post-Training Period</measure>
    <time_frame>difference between baseline and time point two of de-training follow-up period (week 26)</time_frame>
    <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Aspartate Aminotransferase</measure>
    <time_frame>baseline</time_frame>
    <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma Concentration of Alanine Aminotransferase</measure>
    <time_frame>baseline</time_frame>
    <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine</measure>
    <time_frame>baseline</time_frame>
    <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Aging</condition>
  <condition>Immune Function</condition>
  <arm_group>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TDAP</intervention_name>
    <description>Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>tetanus, diptheria, and pertussis vaccination</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acute Resistance Exercise</intervention_name>
    <description>Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle</description>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Single bout of exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Exercise Training</intervention_name>
    <description>Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.</description>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Chronic exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-training Follow-up</intervention_name>
    <description>Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
    <arm_group_label>Nutritional Supplement</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Detraining Period</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional Supplement (Muscle Armor)</intervention_name>
    <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.</description>
    <arm_group_label>Nutritional Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo (Kool-Aid)</intervention_name>
    <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  Age 60-80 years&#xD;
&#xD;
          -  Body Mass Index of 18.5 - 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in any other research study involving an intervention&#xD;
&#xD;
          -  Smokes tobacco products&#xD;
&#xD;
          -  Tetanus or TDAP vaccine in previous two years&#xD;
&#xD;
          -  Allergic to vaccination&#xD;
&#xD;
          -  Seizure in past 3 months&#xD;
&#xD;
          -  Guillain-Barre Syndrome in past 3 months&#xD;
&#xD;
          -  Takes the medications heparin, plavix / clopidogrel, or coumadin / warfarin&#xD;
&#xD;
          -  Allergic to lidocaine&#xD;
&#xD;
          -  Significant problem with fainting&#xD;
&#xD;
          -  Problems walking or exercising with both legs&#xD;
&#xD;
          -  Participated in a weight-lifting program targeting the thighs in last 3 months&#xD;
&#xD;
          -  Pains, tightness or pressure in chest during physical activity&#xD;
&#xD;
          -  Metastatic cancer or undergoing chemotherapy&#xD;
&#xD;
          -  Cerebral aneurysm or intracranial bleed in past year&#xD;
&#xD;
          -  End-stage congestive heart failure (NYHA Stage IV)&#xD;
&#xD;
          -  Unstable abdominal or thoracic aortic aneurysm (&gt;4cm)&#xD;
&#xD;
          -  Renal disease requiring dialysis&#xD;
&#xD;
          -  Allergic to vaccination&#xD;
&#xD;
          -  Acute retinal hemorrhage or ophthalmologic surgery in past 3 months&#xD;
&#xD;
          -  Bone fractures in the pelvis, legs, or feet in the last 3 months&#xD;
&#xD;
          -  Hernia that causes pain during physical activity&#xD;
&#xD;
          -  Myocardial infarction or cardiac surgery in past 3 months&#xD;
&#xD;
          -  Pulmonary embolism or deep venous thrombosis in past 3 months&#xD;
&#xD;
          -  Proliferative diabetic retinopathy or severe nonproliferative retinopathy&#xD;
&#xD;
          -  Active suicidality or suicidal ideation&#xD;
&#xD;
          -  Systemic bacterial infection&#xD;
&#xD;
          -  Taking aspirin in any form and unable/unwilling to discontinue at least 10 days prior&#xD;
             to muscle biopsy&#xD;
&#xD;
          -  Unwilling to halt concurrent use of amino acid or protein supplements&#xD;
&#xD;
          -  Unwilling to halt new use of nutritional supplements&#xD;
&#xD;
          -  Unwilling to maintain current normal diet&#xD;
&#xD;
          -  Encephalopathy in past 7 days&#xD;
&#xD;
          -  Active oral or genital herpes&#xD;
&#xD;
          -  Current use of appetite stimulants&#xD;
&#xD;
          -  Current treatment for mania or bipolar disorder or taking lithium.&#xD;
&#xD;
          -  Diagnosis of a significant cognitive deficit&#xD;
&#xD;
          -  Untreated severe aortic stenosis&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus (HbA1C&gt;10)&#xD;
&#xD;
          -  Uncontrolled hypertension or hypotension (&gt;160/100, &lt;100 systolic)&#xD;
&#xD;
          -  Uncontrolled malignant cardiac arrhythmia&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Allergic to latex or tape&#xD;
&#xD;
          -  Bleeding or clotting disorders&#xD;
&#xD;
          -  Taking any non-ASA NSAID and unable or unwilling to discontinue use for 3 days prior&#xD;
             to muscle biopsy&#xD;
&#xD;
          -  Taking Fish Oil, Gingko, Garlic, Saw Palmetto, Turmeric, or Vitamin E and unable or&#xD;
             unwilling to discontinue use for 10 days prior to the muscle biopsy procedure&#xD;
&#xD;
          -  Significant problems with chronic pain&#xD;
&#xD;
          -  Uncontrolled asthma or allergies&#xD;
&#xD;
          -  Taking lactulose, nitrates plus hypertension medications or Viagra&#xD;
&#xD;
          -  Liver cirrhosis or other severe liver disease&#xD;
&#xD;
          -  History of peripheral artery disease&#xD;
&#xD;
          -  Certain Steroid or androgen use in past 3 months&#xD;
&#xD;
          -  Other physician judgment&#xD;
&#xD;
          -  Significantly abnormal complete blood count (CBC) or prothrombin time (PT)/partial&#xD;
             thromboplastin time (PTT)/international normalized ratio (INR)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard A Dennis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72114-1706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Long DE, Villasante Tezanos AG, Wise JN, Kern PA, Bamman MM, Peterson CA, Dennis RA. A guide for using NIH Image J for single slice cross-sectional area and composition analysis of the thigh from computed tomography. PLoS One. 2019 Feb 7;14(2):e0211629. doi: 10.1371/journal.pone.0211629. eCollection 2019.</citation>
    <PMID>30730923</PMID>
  </reference>
  <results_reference>
    <citation>Dennis RA, Long DE, Landes RD, Padala KP, Padala PR, Garner KK, Wise JN, Peterson CA, Sullivan DH. Tutorial for using SliceOmatic to calculate thigh area and composition from computed tomography images from older adults. PLoS One. 2018 Oct 2;13(10):e0204529. doi: 10.1371/journal.pone.0204529. eCollection 2018.</citation>
    <PMID>30278056</PMID>
  </results_reference>
  <results_reference>
    <citation>Kosmac K, Peck BD, Walton RG, Mula J, Kern PA, Bamman MM, Dennis RA, Jacobs CA, Lattermann C, Johnson DL, Peterson CA. Immunohistochemical Identification of Human Skeletal Muscle Macrophages. Bio Protoc. 2018 Jun 20;8(12):e2883. doi: 10.21769/BioProtoc.2883.</citation>
    <PMID>30148186</PMID>
  </results_reference>
  <results_reference>
    <citation>Dennis RA, Ponnappan U, Kodell RL, Garner KK, Parkes CM, Bopp MM, Padala KP, Peterson CA, Padala PR, Sullivan DH. Immune Function and Muscle Adaptations to Resistance exercise in Older Adults: Study Protocol for a Randomized Controlled Trial of a Nutritional Supplement. Trials. 2015 Mar 27;16:121. doi: 10.1186/s13063-015-0631-3.</citation>
    <PMID>25872570</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>August 26, 2020</results_first_submitted>
  <results_first_submitted_qc>August 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2021</results_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>resistance exercise</keyword>
  <keyword>Juven</keyword>
  <keyword>exercise training</keyword>
  <keyword>interleukin-1</keyword>
  <keyword>insulin-like growth factor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02261961/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02261961/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>59 consented but only 44 randomized due to 15 either being excluded or withdrawal prior to randomization</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Nutritional Supplement</title>
          <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="20">One subject listed as completed who withdrew but finished training phase and has usable data.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Included subjects who completed all or majority of study</population>
      <group_list>
        <group group_id="B1">
          <title>Nutritional Supplement</title>
          <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a post-training Follow-up</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approx 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a Post-training Follow-up</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Age measured in years</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.3" spread="4.8"/>
                    <measurement group_id="B2" value="69.1" spread="5.0"/>
                    <measurement group_id="B3" value="69.2" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Leg Press</title>
          <description>strength in one-repetition max</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="486.7" spread="112.1"/>
                    <measurement group_id="B2" value="519.3" spread="130.6"/>
                    <measurement group_id="B3" value="499.5" spread="118.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Knee Curl</title>
          <description>strength in one-repetition max</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="135.7" spread="37.1"/>
                    <measurement group_id="B2" value="128.2" spread="26.5"/>
                    <measurement group_id="B3" value="130.9" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Knee Extension</title>
          <description>strength in one-repetition max</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136.7" spread="37.1"/>
                    <measurement group_id="B2" value="132.3" spread="37.9"/>
                    <measurement group_id="B3" value="134.0" spread="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Muscle Size</title>
          <description>cross sectional area of thigh</description>
          <units>centimeters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144.5" spread="22.2"/>
                    <measurement group_id="B2" value="139.1" spread="21.0"/>
                    <measurement group_id="B3" value="141.2" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tetanus Antibody Levels</title>
          <description>ELISA measure of blood antibody levels to antigen</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" spread="2.1"/>
                    <measurement group_id="B2" value="3.7" spread="2.5"/>
                    <measurement group_id="B3" value="3.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pertussis Antibody Levels</title>
          <description>ELISA measure of blood antibody levels to antigen</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.8" spread="32.9"/>
                    <measurement group_id="B2" value="59.7" spread="41.2"/>
                    <measurement group_id="B3" value="55.4" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diptheria Antibody Levels</title>
          <description>ELISA measure of blood antibody levels to antigen</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" spread="0.7"/>
                    <measurement group_id="B2" value="0.7" spread="1.0"/>
                    <measurement group_id="B3" value="0.7" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
        <time_frame>change from baseline at 1 week post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: B</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.1" spread="39.7"/>
                    <measurement group_id="O2" value="63.2" spread="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.24275</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
        <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.2" spread="130.7"/>
                    <measurement group_id="O2" value="216.7" spread="240.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>1.3707</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Plasma Concentration of C-Reactive Protein</title>
        <description>Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of C-Reactive Protein</title>
          <description>Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="1.52"/>
                    <measurement group_id="O2" value="-3.96" spread="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)</title>
        <description>The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)</title>
          <description>The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.01" spread="49.36"/>
                    <measurement group_id="O2" value="-8.54" spread="25.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Muscle Strength After Exercise Training for 12 Weeks</title>
        <description>The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training phase (12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Strength After Exercise Training for 12 Weeks</title>
          <description>The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195.4" spread="54.4"/>
                    <measurement group_id="O2" value="182.9" spread="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.35579</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
        <time_frame>change from baseline at 1 week post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="2.4"/>
                    <measurement group_id="O2" value="4.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>0.004493</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
        <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.7"/>
                    <measurement group_id="O2" value="8.2" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>0.870653</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
        <time_frame>change from baseline at 1 week post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.2"/>
                    <measurement group_id="O2" value="1.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.38664</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)</title>
        <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
        <time_frame>change from baseline at 2 weeks post-vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)</title>
          <description>The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.</description>
          <units>units per ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.6"/>
                    <measurement group_id="O2" value="1.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>0.335124</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Muscle Macrophages Per Myofiber (Resting)</title>
        <description>The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Muscle Macrophages Per Myofiber (Resting)</title>
          <description>The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.89" spread="21.99"/>
                    <measurement group_id="O2" value="42.42" spread="51.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Size After Exercise Training for 12 Weeks</title>
        <description>The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training phase (12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Size After Exercise Training for 12 Weeks</title>
          <description>The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.</description>
          <units>centimeters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.8" spread="24.1"/>
                    <measurement group_id="O2" value="146.4" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>0.03145</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Strength at Week 16 of the Post-Training Period</title>
        <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
        <time_frame>difference between baseline and time point one of de-training follow-up period (week 16)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Strength at Week 16 of the Post-Training Period</title>
          <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.5" spread="50.0"/>
                    <measurement group_id="O2" value="162.9" spread="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.43902</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Balance After Exercise Training for 12 Weeks</title>
        <description>The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Balance After Exercise Training for 12 Weeks</title>
          <description>The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="1.27"/>
                    <measurement group_id="O2" value="0.79" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period</title>
        <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
        <time_frame>difference between time of training completion and time point two of de-training follow-up period (26 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period</title>
          <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.49"/>
                    <measurement group_id="O2" value="0.05" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Balance at Week 16 of the Post-Training Period</title>
        <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
        <time_frame>difference between time of training completion and time point one of de-training follow-up period (week 16)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Balance at Week 16 of the Post-Training Period</title>
          <description>The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.49"/>
                    <measurement group_id="O2" value="0.11" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Walking Ability After Exercise Training for 12 Weeks</title>
        <description>The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Walking Ability After Exercise Training for 12 Weeks</title>
          <description>The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.03" spread="31.74"/>
                    <measurement group_id="O2" value="22.25" spread="40.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Walking Ability at Week 16 of the Post-Training Period</title>
        <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
        <time_frame>difference between end of training and time point one of de-training follow-up period (week 16)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Walking Ability at Week 16 of the Post-Training Period</title>
          <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.62" spread="38.91"/>
                    <measurement group_id="O2" value="-29.02" spread="55.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Walking Ability at Week 26 of the Post-Training Period</title>
        <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
        <time_frame>difference between end of training and time point two of de-training follow-up period (week 26)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Walking Ability at Week 26 of the Post-Training Period</title>
          <description>The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="38.24"/>
                    <measurement group_id="O2" value="-20.85" spread="52.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Speed After Exercise Training for 12 Weeks</title>
        <description>The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Speed After Exercise Training for 12 Weeks</title>
          <description>The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.11"/>
                    <measurement group_id="O2" value="0.05" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Speed at Week 16 of the Post-Training Period</title>
        <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
        <time_frame>difference between after training and time point one of de-training follow-up period (week 16)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Speed at Week 16 of the Post-Training Period</title>
          <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.10"/>
                    <measurement group_id="O2" value="-0.03" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Speed During at Week 26 of the Post-Training Period</title>
        <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
        <time_frame>difference between after training and time point two of de-training follow-up period (week 26)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Speed During at Week 26 of the Post-Training Period</title>
          <description>The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.13"/>
                    <measurement group_id="O2" value="0.03" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Size at Week 26 of the Post-Training Period</title>
        <description>The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation.</description>
        <time_frame>difference between baseline and time point two of de-training follow-up period (week 26)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Size at Week 26 of the Post-Training Period</title>
          <description>The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>centimeters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.6" spread="24.4"/>
                    <measurement group_id="O2" value="140.5" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.07603</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Timed Up and Go After Exercise Training for 12 Weeks</title>
        <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Timed Up and Go After Exercise Training for 12 Weeks</title>
          <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.65"/>
                    <measurement group_id="O2" value="-0.26" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Timed Up and Go at Week 16 of the Post-Training Period</title>
        <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
        <time_frame>difference between after training and time point one of de-training follow-up period (week 16)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Timed Up and Go at Week 16 of the Post-Training Period</title>
          <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="1.12"/>
                    <measurement group_id="O2" value="0.18" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Timed Up and Go at Week 26 of the Post-Training Period</title>
        <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
        <time_frame>difference between after training and time point two of de-training follow-up period (week 26)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Timed Up and Go at Week 26 of the Post-Training Period</title>
          <description>The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="1.18"/>
                    <measurement group_id="O2" value="-0.15" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Resting Muscle Concentration of Interleukin-1 Beta</title>
        <description>The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Resting Muscle Concentration of Interleukin-1 Beta</title>
          <description>The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.00" spread="172.57"/>
                    <measurement group_id="O2" value="40.93" spread="148.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise)</title>
        <description>The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise)</title>
          <description>The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.52" spread="424.92"/>
                    <measurement group_id="O2" value="-89.70" spread="2744.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resting Muscle Atrophy Gene MURF Expression</title>
        <description>The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>percent change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Resting Muscle Atrophy Gene MURF Expression</title>
          <description>The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.98" spread="99.61"/>
                    <measurement group_id="O2" value="148.17" spread="325.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise)</title>
        <description>The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise)</title>
          <description>The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.69" spread="224.53"/>
                    <measurement group_id="O2" value="-76.98" spread="423.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resting Muscle Protein Kinase B</title>
        <description>The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Resting Muscle Protein Kinase B</title>
          <description>The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.15" spread="187.21"/>
                    <measurement group_id="O2" value="51.24" spread="112.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Protein Kinase B (Post-acute Exercise)</title>
        <description>The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
        <time_frame>change from baseline at 2 weeks of treatment</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Protein Kinase B (Post-acute Exercise)</title>
          <description>The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.24" spread="127.78"/>
                    <measurement group_id="O2" value="9.48" spread="85.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks</title>
        <description>The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks</title>
          <description>The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.24" spread="48.93"/>
                    <measurement group_id="O2" value="9.96" spread="40.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Myonuclei After Exercise Training for 12 Weeks</title>
        <description>The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Myonuclei After Exercise Training for 12 Weeks</title>
          <description>The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.88" spread="36.99"/>
                    <measurement group_id="O2" value="20.28" spread="27.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Muscle Fiber Size After Exercise Training for 12 Weeks</title>
        <description>The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program.</description>
        <time_frame>change from baseline at completion of exercise training (12 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Fiber Size After Exercise Training for 12 Weeks</title>
          <description>The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.26" spread="51.59"/>
                    <measurement group_id="O2" value="47.28" spread="54.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks</title>
        <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>at completion of the exercise training program (15 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks</title>
          <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.25" spread="7.79"/>
                    <measurement group_id="O2" value="26.37" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks</title>
        <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>completion of the exercise training program (15 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks</title>
          <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.83" spread="13.90"/>
                    <measurement group_id="O2" value="24.53" spread="13.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks</title>
        <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>completion of the exercise training program (15 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks</title>
          <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.40" spread="5.22"/>
                    <measurement group_id="O2" value="13.35" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption</title>
        <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>end of study (42 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption</title>
          <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.31" spread="8.83"/>
                    <measurement group_id="O2" value="27.16" spread="9.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption</title>
        <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>end of study (42 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption</title>
          <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.38" spread="8.49"/>
                    <measurement group_id="O2" value="25.32" spread="10.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption</title>
        <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>end of study (42 weeks)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption</title>
          <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.98" spread="9.10"/>
                    <measurement group_id="O2" value="14.44" spread="4.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Muscle Strength at Week 26 of the Post-Training Period</title>
        <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
        <time_frame>difference between baseline and time point two of de-training follow-up period (week 26)</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Strength at Week 26 of the Post-Training Period</title>
          <description>The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.2" spread="50.6"/>
                    <measurement group_id="O2" value="165.0" spread="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>-0.4745</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Aspartate Aminotransferase</title>
        <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Aspartate Aminotransferase</title>
          <description>Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.62" spread="7.52"/>
                    <measurement group_id="O2" value="27.55" spread="10.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma Concentration of Alanine Aminotransferase</title>
        <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>baseline</time_frame>
        <population>The overall number of participants analyzed was less than the total number of participants due to clinical lab error.</population>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Alanine Aminotransferase</title>
          <description>Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <population>The overall number of participants analyzed was less than the total number of participants due to clinical lab error.</population>
          <units>Units/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.54" spread="6.24"/>
                    <measurement group_id="O2" value="27.42" spread="16.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine</title>
        <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nutritional Supplement</title>
            <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine</title>
          <description>Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.06" spread="3.75"/>
                    <measurement group_id="O2" value="14.52" spread="5.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nutritional Supplement</title>
          <description>Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.&#xD;
TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo&#xD;
Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle&#xD;
Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.&#xD;
Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approx 26 wks after completion of the ex training.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>SAE</sub_title>
                <description>Prior to randomization one subject withdrew for unstated health reasons and one was excluded due to chest pain.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cardiovascular Event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>colon polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>unknown surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>gallstones</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>knee surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>lost name and address</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>gastrointestinal distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>biopsy pain or bruise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>bodily wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>cold, flu, or infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>musculoskeletal soreness, strain, or pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin irritation, rash, or numbness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Richard Dennis</name_or_title>
      <organization>Central Arkansas Veterans Healthcare System</organization>
      <phone>501-257-5583</phone>
      <email>richard.dennis2@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261961
org study id: E1203-R
secondary id: RX001203
secondary id: 608119
nct id: NCT02261961
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The loss of muscle mass and strength due to aging leads to serious health problems for older
      adults. Muscle health can be improved by exercise training, but some people improve their
      strength substantially, whereas others improve little. The reason for this variation is
      unknown. This study will investigate whether function of the immune system influences how
      well people respond to exercise. Older Veterans who participate will have their muscle size,
      strength, and function measured periodically for almost a year. Participants will drink a
      nutritional supplement or placebo daily and complete a 36 session strength training program.
      Participants will be vaccinated for tetanus and donate small amounts of blood and muscle
      tissue during the study so that immune function can be compared to muscle outcomes during
      training and during a long-term follow-up. The study results should increase the
      investigators' understanding of the negative effects of aging on muscle and will possibly
      lead to better strategies for muscle maintenance and rehabilitation for older adults.
Objective: The study will examine the influence of immune function in older adults on
      improvement of muscle mass, strength, and function by resistance training. The maintenance of
      those benefits during long term follow-up will also be examined. This objective will be
      accomplished by a double-blind randomized placebo-controlled trial of a nutritional
      supplement (Muscle Armor) which evidence suggests can improve immune function, promote muscle
      growth, and counteract muscle loss. The study premise is that aging results in decreased
      ability of the immune system to respond to stimuli such as exercise. The study proposes that
      the supplement will improve muscle health by promoting a shift in immune function of older
      adults from a pro-inflammatory state towards a state which supports muscle growth and
      maintenance.

      Research Plan: The study will randomize Veterans (age 60-80, N=50) to participate in the
      supplement or placebo groups in a three phase study. The phases of participation correspond
      to the three specific aims. Aim 1 will determine if 2-weeks of supplementation improves
      immune function. Humoral immune function will be assessed as the response to vaccination.
      Innate immune function will be measured as systemic and cellular responses to acute
      resistance exercise that the investigators' previous studies indicate are affected by aging.
      Aim 2 will determine if supplementation during 36 sessions of progressive high-intensity
      resistance training boosts improvement in muscle size (CT scan), strength, and function (gait
      and balance). Muscle adaptations at the cellular levels will also be measured. Aim 3 will
      determine if continued supplementation for 26-weeks after completion of exercise training
      promotes the retention of the gains in muscle size, strength, and function. Multivariable
      testing will then be used to compare the results between Aims 1, 2, and 3 to determine
      whether or not immune function is correlated with muscle adaptation to training or
      detraining.

      Methods: Participants will undergo nine blood draws and five muscle biopsies of the vastus
      lateralis over the course of the study so that the effects of the supplement on immune
      function and cellular adaptations to training can be measured. Three of the blood draws will
      be used to assess the antibody response to the tetanus, pertussis, and diphtheria vaccine.
      Muscle and blood will be collected before and after a bout of exercise conducted before and
      after the 2-weeks of supplementation prior to training. Immune function will be measured
      using the blood based on pro- and anti-inflammatory cytokine levels, the balance between
      specific T-cell subpopulations, and the proliferative capacity of mononuclear cells. Immune
      function will be measured in muscle based on macrophage content of specific cytokines and
      growth factors. The investigators' previous study showed that these muscle measures strongly
      correlate with size and strength gain after training. Key signaling pathways including
      nuclear factor-k B and PI3 kinase will also be measured. The fifth biopsy will be collected
      post-training to measure adaptation at the cellular level based on changes in number of
      satellite cells and myonuclei and fiber size. Hypotheses related to these measures will be
      tested with 80% power to detect at least 0.8 standard deviations difference in means between
      the supplement and placebo groups.

      Clinical Relevance: Exercise is clearly able to affect immune function. However, the proposed
      study will attempt to modulate immune function and determine the effects on exercise
      outcomes. The study will also examine detraining, an important issue for older adults, that
      is usually omitted from training studies. Thus, the study will potentially advance the
      understanding of the mechanisms of muscle gain and loss in older adults, but more
      importantly, the study will evaluate a nutritional intervention as a complement to exercise
      for supporting muscle health during aging. Targeting the immune system may be the advantage
      needed for an older Veteran to successfully maintain or restore the muscle mass, strength,
      and function that is necessary for personal independence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)
time frame: change from baseline at 1 week post-vaccine
description: The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
measure: Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)
time frame: change from baseline at 2 weeks post-vaccine
description: The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
measure: Change in Plasma Concentration of C-Reactive Protein
time frame: change from baseline at 2 weeks of treatment
description: Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.
measure: Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)
time frame: change from baseline at 2 weeks of treatment
description: The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.
measure: Change in Muscle Strength After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training phase (12 weeks)
description: The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.
measure: Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)
time frame: change from baseline at 1 week post-vaccine
description: The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
measure: Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)
time frame: change from baseline at 2 weeks post-vaccine
description: The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
measure: Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)
time frame: change from baseline at 1 week post-vaccine
description: The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
measure: Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)
time frame: change from baseline at 2 weeks post-vaccine
description: The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
measure: Number of Muscle Macrophages Per Myofiber (Resting)
time frame: change from baseline at 2 weeks of treatment
description: The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.
measure: Change in Muscle Size After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training phase (12 weeks)
description: The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.
measure: Change in Muscle Strength at Week 16 of the Post-Training Period
time frame: difference between baseline and time point one of de-training follow-up period (week 16)
description: The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.
measure: Change in Balance After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program.
measure: Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period
time frame: difference between time of training completion and time point two of de-training follow-up period (26 weeks)
description: The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.
measure: Change in Balance at Week 16 of the Post-Training Period
time frame: difference between time of training completion and time point one of de-training follow-up period (week 16)
description: The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.
measure: Change in Walking Ability After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes.
measure: Change in Walking Ability at Week 16 of the Post-Training Period
time frame: difference between end of training and time point one of de-training follow-up period (week 16)
description: The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.
measure: Change in Walking Ability at Week 26 of the Post-Training Period
time frame: difference between end of training and time point two of de-training follow-up period (week 26)
description: The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.
measure: Change in Gait Speed After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program.
measure: Change in Gait Speed at Week 16 of the Post-Training Period
time frame: difference between after training and time point one of de-training follow-up period (week 16)
description: The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.
measure: Change in Gait Speed During at Week 26 of the Post-Training Period
time frame: difference between after training and time point two of de-training follow-up period (week 26)
description: The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.
measure: Change in Muscle Size at Week 26 of the Post-Training Period
time frame: difference between baseline and time point two of de-training follow-up period (week 26)
description: The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation.
measure: Change in Timed Up and Go After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program.
measure: Change in Timed Up and Go at Week 16 of the Post-Training Period
time frame: difference between after training and time point one of de-training follow-up period (week 16)
description: The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.
measure: Change in Timed Up and Go at Week 26 of the Post-Training Period
time frame: difference between after training and time point two of de-training follow-up period (week 26)
description: The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.
measure: Percent Change in Resting Muscle Concentration of Interleukin-1 Beta
time frame: change from baseline at 2 weeks of treatment
description: The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo.
measure: Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise)
time frame: change from baseline at 2 weeks of treatment
description: The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.
measure: Change in Resting Muscle Atrophy Gene MURF Expression
time frame: percent change from baseline at 2 weeks of treatment
description: The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo.
measure: Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise)
time frame: change from baseline at 2 weeks of treatment
description: The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.
measure: Change in Resting Muscle Protein Kinase B
time frame: change from baseline at 2 weeks of treatment
description: The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo.
measure: Change in Muscle Protein Kinase B (Post-acute Exercise)
time frame: change from baseline at 2 weeks of treatment
description: The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.
measure: Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program.
measure: Change in Number of Myonuclei After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program.
measure: Change in Muscle Fiber Size After Exercise Training for 12 Weeks
time frame: change from baseline at completion of exercise training (12 weeks)
description: The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program.
measure: Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks
time frame: at completion of the exercise training program (15 weeks)
description: Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks
time frame: completion of the exercise training program (15 weeks)
description: Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks
time frame: completion of the exercise training program (15 weeks)
description: Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption
time frame: end of study (42 weeks)
description: Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption
time frame: end of study (42 weeks)
description: Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption
time frame: end of study (42 weeks)
description: Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Change in Muscle Strength at Week 26 of the Post-Training Period
time frame: difference between baseline and time point two of de-training follow-up period (week 26)
description: The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.
measure: Plasma Concentration of Aspartate Aminotransferase
time frame: baseline
description: Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Plasma Concentration of Alanine Aminotransferase
time frame: baseline
description: Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.
measure: Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine
time frame: baseline
description: Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.
arm group label: Nutritional Supplement
arm group type: Experimental
description: Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
intervention type: Biological
intervention name: TDAP
description: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo
arm group label: Nutritional Supplement
arm group label: Placebo
other name: tetanus, diptheria, and pertussis vaccination
intervention type: Other
intervention name: Acute Resistance Exercise
description: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle
arm group label: Nutritional Supplement
arm group label: Placebo
other name: Single bout of exercise
intervention type: Other
intervention name: Resistance Exercise Training
description: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.
arm group label: Nutritional Supplement
arm group label: Placebo
other name: Chronic exercise
intervention type: Other
intervention name: Post-training Follow-up
description: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.
arm group label: Nutritional Supplement
arm group label: Placebo
other name: Detraining Period
intervention type: Dietary Supplement
intervention name: Nutritional Supplement (Muscle Armor)
description: Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
arm group label: Nutritional Supplement
intervention type: Dietary Supplement
intervention name: Placebo (Kool-Aid)
description: Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard A Dennis, PhD
role: Principal Investigator
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
facility: 
country: United States
citation: Long DE, Villasante Tezanos AG, Wise JN, Kern PA, Bamman MM, Peterson CA, Dennis RA. A guide for using NIH Image J for single slice cross-sectional area and composition analysis of the thigh from computed tomography. PLoS One. 2019 Feb 7;14(2):e0211629. doi: 10.1371/journal.pone.0211629. eCollection 2019.
PMID: 30730923
citation: Dennis RA, Long DE, Landes RD, Padala KP, Padala PR, Garner KK, Wise JN, Peterson CA, Sullivan DH. Tutorial for using SliceOmatic to calculate thigh area and composition from computed tomography images from older adults. PLoS One. 2018 Oct 2;13(10):e0204529. doi: 10.1371/journal.pone.0204529. eCollection 2018.
PMID: 30278056
citation: Kosmac K, Peck BD, Walton RG, Mula J, Kern PA, Bamman MM, Dennis RA, Jacobs CA, Lattermann C, Johnson DL, Peterson CA. Immunohistochemical Identification of Human Skeletal Muscle Macrophages. Bio Protoc. 2018 Jun 20;8(12):e2883. doi: 10.21769/BioProtoc.2883.
PMID: 30148186
citation: Dennis RA, Ponnappan U, Kodell RL, Garner KK, Parkes CM, Bopp MM, Padala KP, Peterson CA, Padala PR, Sullivan DH. Immune Function and Muscle Adaptations to Resistance exercise in Older Adults: Study Protocol for a Randomized Controlled Trial of a Nutritional Supplement. Trials. 2015 Mar 27;16:121. doi: 10.1186/s13063-015-0631-3.
PMID: 25872570
responsible party type: Sponsor
mesh term: Sarcopenia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 