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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258346
• Other study ID #: 2017-05-0092
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: February 2019
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Sarcopenia

Intervention

Other:
• Inertial 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).

Dietary Supplement:
• Pomegranate Juice
Subjects will consume 8oz of pomegranate juice daily for duration of study.
• Placebo
Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.

Locations

Country	Name	City	State
United States	Human Performance Laboratory	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle volume	Volume of the thigh musculature as determined by MRI analysis.	Baseline to 11 weeks
Primary	Change in sarcopenia obesity	Intermuscular adipose tissue infiltration as measured by MRI	Baseline to 11 weeks
Primary	Change in aerobic capacity	VO2 Max on a cycle ergometer	Baseline to 11 weeks
Primary	Change in anaerobic capacity	The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate	Baseline to 11 weeks
Primary	Change in muscle fatigue	Muscle aerobic stress as measured by near infrared spectroscopy	Baseline to 11 weeks
Primary	Change in body composition	Fat and fat free regional and total mass as measured by dual x-ray absorptiometry	Baseline to 11 weeks
Primary	Change in maximal power production	The ability to produce power as determined on the cycle ergometer and measured in watts	Baseline to 11 weeks
Secondary	Change in cardiovascular risk factors	Flow mediated dilation and pulse wave velocity	Baseline to 11 weeks
Secondary	Change in urolithins	The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals	Baseline, 2 hrs after consuming first pomegranate or placebo supplement
Secondary	Change in Microbiome	The change in the gut microbiota as a result of supplementation with pomegranate juice.	Baseline, week 10 and week 15
Secondary	Change in maximal isometric strength	The maximal ability to push against a immovable object as measured in the thigh musculature	Baseline to 11 weeks
Secondary	Change in functional tests of living	Movement tasks specific to the daily life of the elderly	Baseline to 11 weeks
Secondary	Change in isokinetic torque	The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified	Baseline to 11 weeks