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CompletedNCT03258346Updated Feb 20, 2019

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

An interventional study of Inertial Load Cycling Training and Pomegranate Juice in Sarcopenia and Cardiovascular Risk Factor, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Sarcopenia
  • Cardiovascular Risk Factor

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Keywords

  • Pomegranate Juice
  • Functional Tasks of Living
03

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 50-70 year old male and females

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Exercise and Pomegranate Juice

    Exercise training with daily consumption of pomegranate juice containing polyphenols

    Other: Inertial Load Cycling Training · Dietary Supplement: Pomegranate Juice

  • Placebo comparator
    Exercise and Placebo

    Exercise training with daily consumption of pomegranate juice with polyphenols removed

    Other: Inertial Load Cycling Training · Dietary Supplement: Placebo

Interventions

  • OtherInertial Load Cycling Training

    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).

    Also known as: High intensity interval training

  • Dietary supplementPomegranate Juice

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

  • Dietary supplementPlacebo

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

05

What researchers measure

Primary outcomes

  1. Change in muscle volume

    Volume of the thigh musculature as determined by MRI analysis.

    Time frame: Baseline to 11 weeks

  2. Change in sarcopenia obesity

    Intermuscular adipose tissue infiltration as measured by MRI

    Time frame: Baseline to 11 weeks

  3. Change in aerobic capacity

    VO2 Max on a cycle ergometer

    Time frame: Baseline to 11 weeks

  4. Change in anaerobic capacity

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

    Time frame: Baseline to 11 weeks

  5. Change in muscle fatigue

    Muscle aerobic stress as measured by near infrared spectroscopy

    Time frame: Baseline to 11 weeks

  6. Change in body composition

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

    Time frame: Baseline to 11 weeks

  7. Change in maximal power production

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

    Time frame: Baseline to 11 weeks

Secondary outcomes

  1. Change in cardiovascular risk factors

    Flow mediated dilation and pulse wave velocity

    Time frame: Baseline to 11 weeks

  2. Change in urolithins

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

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

  3. Change in Microbiome

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

    Time frame: Baseline, week 10 and week 15

  4. Change in maximal isometric strength

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

    Time frame: Baseline to 11 weeks

  5. Change in functional tests of living

    Movement tasks specific to the daily life of the elderly

    Time frame: Baseline to 11 weeks

  6. Change in isokinetic torque

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

    Time frame: Baseline to 11 weeks

06

Study locations

1 site
  • Human Performance Laboratory
    Austin, Texas 78712, United States
07

References and documents

Publications

  • Allen JR, Satiroglu R, Fico B, Tanaka H, Vardarli E, Luci JJ, Coyle EF. Inertial Load Power Cycling Training Increases Muscle Mass and Aerobic Power in Older Adults. Med Sci Sports Exerc. 2021 Jun 1;53(6):1188-1193. doi: 10.1249/MSS.0000000000002588. PubMed 33433149 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03258346
Lead sponsor
University of Texas at Austin
Collaborators
POM Wonderful LLC
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Nov 7, 2017
Primary completion
Dec 15, 2018
Completion
Dec 15, 2018
Last update
Feb 20, 2019

Study contacts

Edward F Coyle, PhD
principal investigator · UT Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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