SarcopeniaNCT03258346
Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice
A study testing Inertial Load Cycling Training and Pomegranate Juice in people with Sarcopenia and Cardiovascular Risk Factor, run by University of Texas at Austin at 1 site in United States.
Trial summary
A research study regarding the body's response to several weeks of training using short sprints and pomegranate juice supplementation Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Cardiovascular Risk Factor
- What is being tested?
- Inertial Load Cycling Training and Pomegranate Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-70 year old male and females
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sarcopenia, Cardiovascular Risk Factor
- Being tested
- Inertial Load Cycling Training, Pomegranate Juice, Placebo
- Keywords
- Pomegranate Juice, Functional Tasks of Living
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial Load Cycling TrainingOther
Also called High intensity interval 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).
Pomegranate JuiceDietary supplement
Subjects will consume 8oz of pomegranate juice daily for duration of study.
PlaceboDietary supplement
Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Pomegranate Juice | Experimental | Exercise training with daily consumption of pomegranate juice containing polyphenols Receives: Other: Inertial Load Cycling Training; Dietary Supplement: Pomegranate Juice |
| Exercise and Placebo | Placebo comparator | Exercise training with daily consumption of pomegranate juice with polyphenols removed Receives: Other: Inertial Load Cycling Training; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle volume
Volume of the thigh musculature as determined by MRI analysis.
Measured: Baseline to 11 weeks
Change in sarcopenia obesity
Intermuscular adipose tissue infiltration as measured by MRI
Measured: Baseline to 11 weeks
Change in aerobic capacity
VO2 Max on a cycle ergometer
Measured: Baseline to 11 weeks
Change in anaerobic capacity
The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate
Measured: Baseline to 11 weeks
Change in muscle fatigue
Muscle aerobic stress as measured by near infrared spectroscopy
Measured: Baseline to 11 weeks
Change in body composition
Fat and fat free regional and total mass as measured by dual x-ray absorptiometry
Measured: Baseline to 11 weeks
Change in maximal power production
The ability to produce power as determined on the cycle ergometer and measured in watts
Measured: Baseline to 11 weeks
Secondary outcomes (6)
Change in cardiovascular risk factors
Flow mediated dilation and pulse wave velocity
Measured: Baseline to 11 weeks
Change in urolithins
The ability to breakdown the beneficial components of pomegranate juice into urolithins is different among individuals
Measured: Baseline, 2 hrs after consuming first pomegranate or placebo supplement
Change in Microbiome
The change in the gut microbiota as a result of supplementation with pomegranate juice.
Measured: Baseline, week 10 and week 15
Change in maximal isometric strength
The maximal ability to push against a immovable object as measured in the thigh musculature
Measured: Baseline to 11 weeks
Change in functional tests of living
Movement tasks specific to the daily life of the elderly
Measured: Baseline to 11 weeks
Change in isokinetic torque
The subject will exert maximal leg extension at two speeds and the maximal torque generated will be quantified
Measured: Baseline to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start7 Nov 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- POM Wonderful LLC
- Responsible party
- Sponsor
- Investigators
- Edward F Coyle, PhD, Principal investigator, UT Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258346
- Sponsor's protocol ID
- 2017-05-0092
- Status last verified
- Feb 2019
- First submitted
- 12 Jul 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Muscle Loss With Exercise Training and Daily Consumption of Pomegranate Juice
- ClinicalTrials.gov ID
- NCT03258346
- Acronym / sponsor ID
- 2017-05-0092
- Conditions
- Sarcopenia, Cardiovascular Risk Factor
- Keywords
- Pomegranate Juice, Functional Tasks of Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- POM Wonderful LLC
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Pomegranate Juice | Experimental | Other: Inertial Load Cycling Training, Dietary Supplement: Pomegranate JuiceExercise training with daily consumption of pomegranate juice containing polyphenols |
| Exercise and Placebo | Placebo comparator | Other: Inertial Load Cycling Training, Dietary Supplement: PlaceboExercise training with daily consumption of pomegranate juice with polyphenols removed |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-70 year old male and females
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inertial Load Cycling TrainingAlso: High intensity interval trainingEach 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 | Exercise and Placebo, Exercise and Pomegranate Juice |
| Pomegranate JuiceSubjects will consume 8oz of pomegranate juice daily for duration of study. | Dietary supplement | Exercise and Pomegranate Juice |
| PlaceboSubjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed. | Dietary supplement | Exercise and Placebo |
Primary outcome
Change in muscle volume
Time frame: Baseline to 11 weeks
Volume of the thigh musculature as determined by MRI analysis.
Change in sarcopenia obesity
Time frame: Baseline to 11 weeks
Intermuscular adipose tissue infiltration as measured by MRI
Change in aerobic capacity
Time frame: Baseline to 11 weeks
VO2 Max on a cycle ergometer
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
Change in muscle fatigue
Time frame: Baseline to 11 weeks
Muscle aerobic stress as measured by near infrared spectroscopy
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
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
6 secondary outcomes
Change in cardiovascular risk factors
Time frame: Baseline to 11 weeks
Change in urolithins
Time frame: Baseline, 2 hrs after consuming first pomegranate or placebo supplement
Change in Microbiome
Time frame: Baseline, week 10 and week 15
Change in maximal isometric strength
Time frame: Baseline to 11 weeks
Change in functional tests of living
Time frame: Baseline to 11 weeks
Change in isokinetic torque
Time frame: Baseline to 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 33433149Allen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F Coyle, PhD principal investigator
UT Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inertial Load Cycling Training and Pomegranate Juice in people with Sarcopenia and Cardiovascular Risk Factor, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle volume (time frame: Baseline to 11 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.