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

Primary Purpose

Sarcopenia, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inertial Load Cycling Training
Pomegranate Juice
Placebo
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Pomegranate Juice, Functional Tasks of Living

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Performance Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise and Pomegranate Juice

Exercise and Placebo

Arm Description

Exercise training with daily consumption of pomegranate juice containing polyphenols

Exercise training with daily consumption of pomegranate juice with polyphenols removed

Outcomes

Primary Outcome Measures

Change in muscle volume
Volume of the thigh musculature as determined by MRI analysis.
Change in sarcopenia obesity
Intermuscular adipose tissue infiltration as measured by MRI
Change in aerobic capacity
VO2 Max on a cycle ergometer
Change in anaerobic capacity
The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate
Change in muscle fatigue
Muscle aerobic stress as measured by near infrared spectroscopy
Change in body composition
Fat and fat free regional and total mass as measured by dual x-ray absorptiometry
Change in maximal power production
The ability to produce power as determined on the cycle ergometer and measured in watts

Secondary Outcome Measures

Change in cardiovascular risk factors
Flow mediated dilation and pulse wave velocity
Change in urolithins
The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals
Change in Microbiome
The change in the gut microbiota as a result of supplementation with pomegranate juice.
Change in maximal isometric strength
The maximal ability to push against a immovable object as measured in the thigh musculature
Change in functional tests of living
Movement tasks specific to the daily life of the elderly
Change in isokinetic torque
The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified

Full Information

First Posted
July 12, 2017
Last Updated
February 19, 2019
Sponsor
University of Texas at Austin
Collaborators
POM Wonderful LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03258346
Brief Title
Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice
Official Title
Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
POM Wonderful LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Cardiovascular Risk Factor
Keywords
Pomegranate Juice, Functional Tasks of Living

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Pomegranate juice will be administered in double blind placebo controlled method. Coding will be established by POM Wonderful, LLC.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Pomegranate Juice
Arm Type
Experimental
Arm Description
Exercise training with daily consumption of pomegranate juice containing polyphenols
Arm Title
Exercise and Placebo
Arm Type
Placebo Comparator
Arm Description
Exercise training with daily consumption of pomegranate juice with polyphenols removed
Intervention Type
Other
Intervention Name(s)
Inertial Load Cycling Training
Other Intervention Name(s)
High intensity interval training
Intervention 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate Juice
Intervention Description
Subjects will consume 8oz of pomegranate juice daily for duration of study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.
Primary Outcome Measure Information:
Title
Change in muscle volume
Description
Volume of the thigh musculature as determined by MRI analysis.
Time Frame
Baseline to 11 weeks
Title
Change in sarcopenia obesity
Description
Intermuscular adipose tissue infiltration as measured by MRI
Time Frame
Baseline to 11 weeks
Title
Change in aerobic capacity
Description
VO2 Max on a cycle ergometer
Time Frame
Baseline to 11 weeks
Title
Change in anaerobic capacity
Description
The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate
Time Frame
Baseline to 11 weeks
Title
Change in muscle fatigue
Description
Muscle aerobic stress as measured by near infrared spectroscopy
Time Frame
Baseline to 11 weeks
Title
Change in body composition
Description
Fat and fat free regional and total mass as measured by dual x-ray absorptiometry
Time Frame
Baseline to 11 weeks
Title
Change in maximal power production
Description
The ability to produce power as determined on the cycle ergometer and measured in watts
Time Frame
Baseline to 11 weeks
Secondary Outcome Measure Information:
Title
Change in cardiovascular risk factors
Description
Flow mediated dilation and pulse wave velocity
Time Frame
Baseline to 11 weeks
Title
Change in urolithins
Description
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
Title
Change in Microbiome
Description
The change in the gut microbiota as a result of supplementation with pomegranate juice.
Time Frame
Baseline, week 10 and week 15
Title
Change in maximal isometric strength
Description
The maximal ability to push against a immovable object as measured in the thigh musculature
Time Frame
Baseline to 11 weeks
Title
Change in functional tests of living
Description
Movement tasks specific to the daily life of the elderly
Time Frame
Baseline to 11 weeks
Title
Change in isokinetic torque
Description
The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified
Time Frame
Baseline to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward F Coyle, PhD
Organizational Affiliation
UT Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Performance Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33433149
Citation
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.
Results Reference
derived

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

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