<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/NCT01714479</url>
  </required_header>
  <id_info>
    <org_study_id>12-18-HC</org_study_id>
    <nct_id>NCT01714479</nct_id>
  </id_info>
  <brief_title>Skeletal Muscle Response to Amino Acids and Load Carriage Exercise</brief_title>
  <official_title>Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Army Research Institute of Environmental Medicine</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Army Natick Soldier Research, Development &amp; Engineering Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>United States Army Research Institute of Environmental Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Warfighters often experience physical overload, as the uniform and associated gear that they&#xD;
      carry burdens them with substantial loads. The loads increase energy expenditure to levels&#xD;
      that exceed a Warfighter's typical energy intake. The typical assault load is approximately&#xD;
      25 kg, although loads as high as 55 kg are often carried, which when combined with extreme&#xD;
      energy expenditures can degrade health and performance, and increase the risk of injury.&#xD;
      Branched-chain amino acid (leucine) supplementation may confer protection against the&#xD;
      negative effects of operational stress by stimulating muscle protein synthesis and reducing&#xD;
      degradation. This study will determine if leucine-enriched nutrition supplementation confers&#xD;
      protection against the negative consequences of sustained load carriage exercise, and explore&#xD;
      the mechanisms by which leucine might impart protection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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 muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation</measure>
    <time_frame>90 min exercise bout (exercise) and 180 min of recovery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation</measure>
    <time_frame>4, 24, 48, and 72 hours post exercise</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Muscle Loss</condition>
  <condition>Muscle Anabolism</condition>
  <condition>Muscle Performance</condition>
  <arm_group>
    <arm_group_label>Load Carriage - Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Load Carriage - with a calorie-free placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Load Carriage - leucine-enriched nutrition supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Load Carriage with leucine-enriched amino acid supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Exercise - Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional Exercise with a calorie-free placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Exercise - Leucine-enriched Nutrition Supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional Exercise with leucine-enriched Amino Acid supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leucine-enriched nutritional supplement</intervention_name>
    <description>A protein and carbohydrate supplement with high levels of leucine</description>
    <arm_group_label>Conventional Exercise - Leucine-enriched Nutrition Supplement</arm_group_label>
    <arm_group_label>Load Carriage - leucine-enriched nutrition supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Conventional Exercise - Control</arm_group_label>
    <arm_group_label>Load Carriage - Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 -&#xD;
             60 ml/kg/min&#xD;
&#xD;
          -  Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®),&#xD;
             or any aspirin-containing products, alchohol, and nicotine&#xD;
&#xD;
          -  Females must be on oral contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic or cardiovascular abnormalities, gastrointestinal disorders&#xD;
&#xD;
          -  Disease or medication that affects macronutrient metabolism or the ability to&#xD;
             participate in strenuous exercise&#xD;
&#xD;
          -  Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian&#xD;
             practices, or medications (including, but not limited to, lidocaine or phenylalanine)&#xD;
             to be used in the study&#xD;
&#xD;
          -  Anemia (HCT &lt;38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with&#xD;
             blood clotting&#xD;
&#xD;
          -  Present condition of alcoholism, use of nutritional/sports supplements, anabolic&#xD;
             steroids, or other substance abuse issues&#xD;
&#xD;
          -  Musculoskeletal injuries that compromise the ability to exercise&#xD;
&#xD;
          -  Blood donation within 8 weeks of enrollment&#xD;
&#xD;
          -  Pregnancy and women not on oral contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan M Pasiakos, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>United States Army Research Institute of Environmental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>US Army Research Institute of Environmental Medicine</name>
      <address>
        <city>Natick</city>
        <state>Massachusetts</state>
        <zip>01760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.</citation>
    <PMID>28386239</PMID>
  </reference>
  <results_reference>
    <citation>Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.</citation>
    <PMID>26474292</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01714479
org study id: 12-18-HC
nct id: NCT01714479
lead sponsor: 
collaborator: 
has dmc: No
Warfighters often experience physical overload, as the uniform and associated gear that they
      carry burdens them with substantial loads. The loads increase energy expenditure to levels
      that exceed a Warfighter's typical energy intake. The typical assault load is approximately
      25 kg, although loads as high as 55 kg are often carried, which when combined with extreme
      energy expenditures can degrade health and performance, and increase the risk of injury.
      Branched-chain amino acid (leucine) supplementation may confer protection against the
      negative effects of operational stress by stimulating muscle protein synthesis and reducing
      degradation. This study will determine if leucine-enriched nutrition supplementation confers
      protection against the negative consequences of sustained load carriage exercise, and explore
      the mechanisms by which leucine might impart protection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation
time frame: 90 min exercise bout (exercise) and 180 min of recovery
measure: Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation
time frame: 4, 24, 48, and 72 hours post exercise
arm group label: Load Carriage - Control
arm group type: Placebo Comparator
description: Load Carriage - with a calorie-free placebo
arm group label: Load Carriage - leucine-enriched nutrition supplement
arm group type: Experimental
description: Load Carriage with leucine-enriched amino acid supplementation
arm group label: Conventional Exercise - Control
arm group type: Placebo Comparator
description: Conventional Exercise with a calorie-free placebo
arm group label: Conventional Exercise - Leucine-enriched Nutrition Supplement
arm group type: Active Comparator
description: Conventional Exercise with leucine-enriched Amino Acid supplementation
intervention type: Other
intervention name: Leucine-enriched nutritional supplement
description: A protein and carbohydrate supplement with high levels of leucine
arm group label: Conventional Exercise - Leucine-enriched Nutrition Supplement
arm group label: Load Carriage - leucine-enriched nutrition supplement
intervention type: Other
intervention name: Placebo
arm group label: Conventional Exercise - Control
arm group label: Load Carriage - Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan M Pasiakos, Ph.D.
role: Principal Investigator
affiliation: United States Army Research Institute of Environmental Medicine
facility: 
country: United States
citation: Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.
PMID: 28386239
citation: Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.
PMID: 26474292
responsible party type: Sponsor
sharing ipd: Undecided