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Completed

NCT Number: NCT03258346

Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice

A research study regarding the body's response to several weeks of training using short sprints and pomegranate juice supplementation

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Performance Laboratory

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50-70 year old male and females

Exclusion criteria

  • not currently exercising regularly
  • meets criteria for MRI scanning at Imaging Research Center at UT Austin
  • history of heart disease
  • knee/hip joint problems
  • determination by the physician monitoring pre inclusion stress test

Treatment and study plan

Inertial Load Cycling Training

Other

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).

Other names: High intensity interval training

Pomegranate Juice

Dietary Supplement

Subjects will consume 8oz of pomegranate juice daily for duration of study.

Placebo

Dietary Supplement

Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.

Primary outcomes

  1. Change in muscle volume

    Time frame: Baseline to 11 weeks

    Volume of the thigh musculature as determined by MRI analysis.

  2. Change in sarcopenia obesity

    Time frame: Baseline to 11 weeks

    Intermuscular adipose tissue infiltration as measured by MRI

  3. Change in aerobic capacity

    Time frame: Baseline to 11 weeks

    VO2 Max on a cycle ergometer

  4. Change in anaerobic capacity

    Time frame: Baseline to 11 weeks

    The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate

  5. Change in muscle fatigue

    Time frame: Baseline to 11 weeks

    Muscle aerobic stress as measured by near infrared spectroscopy

  6. Change in body composition

    Time frame: Baseline to 11 weeks

    Fat and fat free regional and total mass as measured by dual x-ray absorptiometry

  7. Change in maximal power production

    Time frame: Baseline to 11 weeks

    The ability to produce power as determined on the cycle ergometer and measured in watts

Secondary outcomes

  1. Change in cardiovascular risk factors

    Time frame: Baseline to 11 weeks

    Flow mediated dilation and pulse wave velocity

  2. Change in urolithins

    Time frame: Baseline, 2 hrs after consuming first pomegranate or placebo supplement

    The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals

  3. Change in Microbiome

    Time frame: Baseline, week 10 and week 15

    The change in the gut microbiota as a result of supplementation with pomegranate juice.

  4. Change in maximal isometric strength

    Time frame: Baseline to 11 weeks

    The maximal ability to push against a immovable object as measured in the thigh musculature

  5. Change in functional tests of living

    Time frame: Baseline to 11 weeks

    Movement tasks specific to the daily life of the elderly

  6. Change in isokinetic torque

    Time frame: Baseline to 11 weeks

    The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • POM Wonderful LLC

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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