<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/NCT03258346</url>
  </required_header>
  <id_info>
    <org_study_id>2017-05-0092</org_study_id>
    <nct_id>NCT03258346</nct_id>
  </id_info>
  <brief_title>Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice</brief_title>
  <official_title>Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>POM Wonderful LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A research study regarding the body's response to several weeks of training using short&#xD;
      sprints and pomegranate juice supplementation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators have shown that chronic pomegranate juice consumption in both young&#xD;
      untrained and weight-trained men partially protects muscles against the damage done from&#xD;
      performing high intensity eccentric contractions and that it accelerates recovery of&#xD;
      function. Clearly, skeletal muscle is a target for some of the healthful molecules in&#xD;
      pomegranate juice. However, the most widespread and serious ailment to strike skeletal muscle&#xD;
      is sarcopenia (e.g.; loss of muscle mass and becoming 'frail') with age due predominantly to&#xD;
      a loss of 'fast-twitch' muscle fibers. Since adults rarely sprint or exert maximal force or&#xD;
      power, they rarely use their fast-twitch muscle fibers, which thus degenerate greatly with&#xD;
      age. Usually, about one-half of a person's muscle fibers are fast-twitch. It is the&#xD;
      investigators' hypothesis that the combination of power exercise training and pomegranate&#xD;
      juice supplementation (POM) over 10 weeks, will elicit greater improvements in maximal&#xD;
      muscular power and functional physical abilities compared to power training with a placebo.&#xD;
      The investigators also will identify changes in size and composition of leg muscles (MRI) and&#xD;
      of the whole body (DEXA). The investigators simple logic is that muscles deteriorate with age&#xD;
      because they are 'turned-off' and that exercise training can turn them 'back-on', but in&#xD;
      order for the muscle fibers to fully repair when turned 'back-on' with exercise, they might&#xD;
      benefit from agents known to foster repair, such as the natural polyphenols in pomegranate&#xD;
      juice. It has recently been found that polyphenols are metabolized into urolithins which&#xD;
      improve muscle cell function due to increased mitophagy. The investigators aim to determine&#xD;
      if power training and pomegranate juice have additive effects in promoting improvements of&#xD;
      muscle function and mass in men and women age 50-70 y.&#xD;
&#xD;
      A second purpose is to include a cardio-metabolic exercise training stimulus into the workout&#xD;
      without compromising the efficacy of the power training. One feature of cardio-metabolic&#xD;
      training is an increase in muscle mitochondria and oxygen utilization which might improve&#xD;
      muscle fiber repair. The 'power training' will consist of maximal effort 4 sec sprints on a&#xD;
      cycle ergometer with no added resistance with the only load being that of the inertia of the&#xD;
      flywheel as the subject accelerates from 0 to their maximal RPM's while cycling (100-150&#xD;
      RPM)('inertial load ergometer'; ILE). The power training will be accomplished by having the&#xD;
      subject complete 15-30 sprints in a 15 min period. During the training bouts, initially the&#xD;
      subjects will rest 56 s between sprints (week 1- complete 15 sprints in each15 min bout), and&#xD;
      then 41 s between sprints (weeks 2-5 and complete 20 sprints) and finally 26 s between&#xD;
      sprints (weeks 6-10 and complete 30 sprints). The shorter rest periods (41 s and 26 s) will&#xD;
      result in incomplete recovery of the cardio-respiratory system and thus the oxygen&#xD;
      consumption and heart rate will average 50-70% of maximal values, which is a similar&#xD;
      intensity as jogging, but without the jarring of foot strike.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">December 15, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Pomegranate juice will be administered in double blind placebo controlled method. Coding will be established by POM Wonderful, LLC.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in muscle volume</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Volume of the thigh musculature as determined by MRI analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sarcopenia obesity</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Intermuscular adipose tissue infiltration as measured by MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aerobic capacity</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>VO2 Max on a cycle ergometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anaerobic capacity</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in muscle fatigue</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Muscle aerobic stress as measured by near infrared spectroscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Fat and fat free regional and total mass as measured by dual x-ray absorptiometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximal power production</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>The ability to produce power as determined on the cycle ergometer and measured in watts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular risk factors</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Flow mediated dilation and pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urolithins</measure>
    <time_frame>Baseline, 2 hrs after consuming first pomegranate or placebo supplement</time_frame>
    <description>The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Microbiome</measure>
    <time_frame>Baseline, week 10 and week 15</time_frame>
    <description>The change in the gut microbiota as a result of supplementation with pomegranate juice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximal isometric strength</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>The maximal ability to push against a immovable object as measured in the thigh musculature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional tests of living</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>Movement tasks specific to the daily life of the elderly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in isokinetic torque</measure>
    <time_frame>Baseline to 11 weeks</time_frame>
    <description>The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Exercise and Pomegranate Juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise training with daily consumption of pomegranate juice containing polyphenols</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Exercise training with daily consumption of pomegranate juice with polyphenols removed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inertial Load Cycling Training</intervention_name>
    <description>Each session of training will require a total of 15 min with the total time actually exercising of only 60-120 sec. The first week will consist of performing 15 'sprints' on the ILE, beginning each sprint with 56 sec of rest. During week 2-5, subjects will rest 41 sec between sprints, completing 20 bouts. Finally, during weeks 6-10, subjects will take 26 s rest between sprints and complete 30 bouts).</description>
    <arm_group_label>Exercise and Placebo</arm_group_label>
    <arm_group_label>Exercise and Pomegranate Juice</arm_group_label>
    <other_name>High intensity interval training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pomegranate Juice</intervention_name>
    <description>Subjects will consume 8oz of pomegranate juice daily for duration of study.</description>
    <arm_group_label>Exercise and Pomegranate Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.</description>
    <arm_group_label>Exercise and Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-70 year old male and females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not currently exercising regularly&#xD;
&#xD;
          -  meets criteria for MRI scanning at Imaging Research Center at UT Austin&#xD;
&#xD;
          -  history of heart disease&#xD;
&#xD;
          -  knee/hip joint problems&#xD;
&#xD;
          -  determination by the physician monitoring pre inclusion stress test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward F Coyle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Performance Laboratory</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pomegranate Juice</keyword>
  <keyword>Functional Tasks of Living</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>
  <!-- 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/NCT03258346
org study id: 2017-05-0092
nct id: NCT03258346
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A research study regarding the body's response to several weeks of training using short
      sprints and pomegranate juice supplementation
The investigators have shown that chronic pomegranate juice consumption in both young
      untrained and weight-trained men partially protects muscles against the damage done from
      performing high intensity eccentric contractions and that it accelerates recovery of
      function. Clearly, skeletal muscle is a target for some of the healthful molecules in
      pomegranate juice. However, the most widespread and serious ailment to strike skeletal muscle
      is sarcopenia (e.g.; loss of muscle mass and becoming 'frail') with age due predominantly to
      a loss of 'fast-twitch' muscle fibers. Since adults rarely sprint or exert maximal force or
      power, they rarely use their fast-twitch muscle fibers, which thus degenerate greatly with
      age. Usually, about one-half of a person's muscle fibers are fast-twitch. It is the
      investigators' hypothesis that the combination of power exercise training and pomegranate
      juice supplementation (POM) over 10 weeks, will elicit greater improvements in maximal
      muscular power and functional physical abilities compared to power training with a placebo.
      The investigators also will identify changes in size and composition of leg muscles (MRI) and
      of the whole body (DEXA). The investigators simple logic is that muscles deteriorate with age
      because they are 'turned-off' and that exercise training can turn them 'back-on', but in
      order for the muscle fibers to fully repair when turned 'back-on' with exercise, they might
      benefit from agents known to foster repair, such as the natural polyphenols in pomegranate
      juice. It has recently been found that polyphenols are metabolized into urolithins which
      improve muscle cell function due to increased mitophagy. The investigators aim to determine
      if power training and pomegranate juice have additive effects in promoting improvements of
      muscle function and mass in men and women age 50-70 y.

      A second purpose is to include a cardio-metabolic exercise training stimulus into the workout
      without compromising the efficacy of the power training. One feature of cardio-metabolic
      training is an increase in muscle mitochondria and oxygen utilization which might improve
      muscle fiber repair. The 'power training' will consist of maximal effort 4 sec sprints on a
      cycle ergometer with no added resistance with the only load being that of the inertia of the
      flywheel as the subject accelerates from 0 to their maximal RPM's while cycling (100-150
      RPM)('inertial load ergometer'; ILE). The power training will be accomplished by having the
      subject complete 15-30 sprints in a 15 min period. During the training bouts, initially the
      subjects will rest 56 s between sprints (week 1- complete 15 sprints in each15 min bout), and
      then 41 s between sprints (weeks 2-5 and complete 20 sprints) and finally 26 s between
      sprints (weeks 6-10 and complete 30 sprints). The shorter rest periods (41 s and 26 s) will
      result in incomplete recovery of the cardio-respiratory system and thus the oxygen
      consumption and heart rate will average 50-70% of maximal values, which is a similar
      intensity as jogging, but without the jarring of foot strike.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Pomegranate juice will be administered in double blind placebo controlled method. Coding will be established by POM Wonderful, LLC.
measure: Change in muscle volume
time frame: Baseline to 11 weeks
description: Volume of the thigh musculature as determined by MRI analysis.
measure: Change in sarcopenia obesity
time frame: Baseline to 11 weeks
description: Intermuscular adipose tissue infiltration as measured by MRI
measure: Change in aerobic capacity
time frame: Baseline to 11 weeks
description: VO2 Max on a cycle ergometer
measure: Change in anaerobic capacity
time frame: Baseline to 11 weeks
description: The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate
measure: Change in muscle fatigue
time frame: Baseline to 11 weeks
description: Muscle aerobic stress as measured by near infrared spectroscopy
measure: Change in body composition
time frame: Baseline to 11 weeks
description: Fat and fat free regional and total mass as measured by dual x-ray absorptiometry
measure: Change in maximal power production
time frame: Baseline to 11 weeks
description: The ability to produce power as determined on the cycle ergometer and measured in watts
measure: Change in cardiovascular risk factors
time frame: Baseline to 11 weeks
description: Flow mediated dilation and pulse wave velocity
measure: Change in urolithins
time frame: Baseline, 2 hrs after consuming first pomegranate or placebo supplement
description: The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals
measure: Change in Microbiome
time frame: Baseline, week 10 and week 15
description: The change in the gut microbiota as a result of supplementation with pomegranate juice.
measure: Change in maximal isometric strength
time frame: Baseline to 11 weeks
description: The maximal ability to push against a immovable object as measured in the thigh musculature
measure: Change in functional tests of living
time frame: Baseline to 11 weeks
description: Movement tasks specific to the daily life of the elderly
measure: Change in isokinetic torque
time frame: Baseline to 11 weeks
description: The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified
arm group label: Exercise and Pomegranate Juice
arm group type: Experimental
description: Exercise training with daily consumption of pomegranate juice containing polyphenols
arm group label: Exercise and Placebo
arm group type: Placebo Comparator
description: Exercise training with daily consumption of pomegranate juice with polyphenols removed
intervention type: Other
intervention name: Inertial Load Cycling Training
description: Each session of training will require a total of 15 min with the total time actually exercising of only 60-120 sec. The first week will consist of performing 15 'sprints' on the ILE, beginning each sprint with 56 sec of rest. During week 2-5, subjects will rest 41 sec between sprints, completing 20 bouts. Finally, during weeks 6-10, subjects will take 26 s rest between sprints and complete 30 bouts).
arm group label: Exercise and Placebo
arm group label: Exercise and Pomegranate Juice
other name: High intensity interval training
intervention type: Dietary Supplement
intervention name: Pomegranate Juice
description: Subjects will consume 8oz of pomegranate juice daily for duration of study.
arm group label: Exercise and Pomegranate Juice
intervention type: Dietary Supplement
intervention name: Placebo
description: Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.
arm group label: Exercise and Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward F Coyle, PhD
role: Principal Investigator
affiliation: UT Austin
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sarcopenia
sharing ipd: No