Mobility DisabilityPhase 1/2COMETNCT07161726
Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial
A Phase 1/2 study testing (-)-Epicatechin-rich cocoa supplementation combined with exercise training in people with Mobility Disability, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to see if regular exercise when combined with a cocoa supplement will improve physical performance and muscle strength compared to regular exercise alone. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mobility Disability
- What is being tested?
- (-)-Epicatechin-rich cocoa supplementation combined with exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 years and older
- Slow walking speed of < 1m/s
- Willingness to be randomized to either treatment group
- Willingness to participate in all study procedures (muscle biopsy will be optional)
Who cannot join
- Failure to provide informed consent;
- Regular consumption of flavanol and/or cocoa supplements
- Current involvement in supervised rehabilitation/exercise training program
- Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines [17]
- Daytime average of systolic blood pressure ≥ 180/100mm Hg.
- Refusal to stop blood thinners such as baby aspirin dose.
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- Peripheral vascular disease; peripheral neuropathy; retinopathy
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
- Myocardial infarction or stroke within past year
- Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score < 24
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis;
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease;
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
- Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
- Simultaneous participation in another interventional trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of the study is to see if regular exercise when combined with a cocoa supplement will improve physical performance and muscle strength compared to regular exercise alone.
Read the detailed description
Diminished mitochondrial function, excessive production of reactive oxygen species (ROS) and mitochondrial DNA (mtDNA) damage are key contributors to age-related physical capacity and muscle strength decline. Adaptation to aerobic and strength exercise training is currently one of the most effective ways to preserve physical performance and muscle strength in older adults. Aerobic and resistance exercise training improves mitochondrial function and stabilizes production of ROS, which contribute to aerobic capacity as well as strength improvements. However, obtaining optimal effects of exercise training may be limited by heterogeneity in the responsiveness due to biological barriers in skeletal muscle energy production, regardless of the adherence. Therefore, there is an unmet need for combining non-pharmacologic therapies with exercise training to "unlock" its full energetic potential to more effectively improve physical performance and muscle strength in older adults at risk of mobility disability. (-)-Epicatechin, a flavanol and a major ingredient present in cocoa, improved survival, muscle mitochondrial function and reduced excess ROS in mice. Supplementation with (-)-epicatechin-rich cocoa improved walking performance and muscle strength in older adults. Combination of (-)-epicatechin with exercise further improved mitochondrial function and reduced muscle fatigue in mice. We hypothesize that the combination of (-)-epicatechin-rich cocoa with structured aerobic and resistance exercise training will be more effective than exercise alone in improving physical performance and muscle strength by improved mitochondrial function and reduced ROS production in moderately functioning older adults. Our proposed pilot trial will test a 3-month exercise training intervention to collect preliminary data on walking performance, muscle strength and muscle size in 36 moderately functioning (slow walking speed <1m/s) older adults (>55 years old) without major comorbidities. The participants will be randomized to 12-week of daily (-)-epicatechin-rich cocoa (2 capsules/d containing 450 mg cocoa flavanols/day, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week (Epi+Ex, n=18) or the same exercise training regimen combined with cellulose-based blind (PL+Ex, n=18). Our primary outcome is walking distance measured by the 6-minute walk test. The lower-limb muscle strength and size measured by the Biodex test will be our secondary outcome. We will explore the potential mechanism of the hypothesized effect of Epi+Ex on walking performance and muscle strength by measuring mitochondrial biogenesis, mitochondrial DNA damage, ROS production and antioxidant enzyme activity in the vastus lateralis biopsies at baseline and 12-week follow-up. The objective of this exploratory/developmental proposal is to gather preliminary data on the efficacy and explore the mechanism of the Epi-Ex intervention to support the future Phase II clinical trial testing (-)-epicatechin-rich cocoa flavanols for exercise training optimization in older adults.
- Conditions
- Mobility Disability
- Being tested
- (-)-Epicatechin-rich cocoa supplementation combined with exercise training, Placebo combined with exercise training
- Keywords
- Cocoa, Exercise, Mobility, Older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(-)-Epicatechin-rich cocoa supplementation combined with exercise trainingCombination product
12 weeks of daily cocoa (2 capsules/d containing 450 mg cocoa flavanols/d, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (30 min of whole-body workout) exercise training 3 times a week
Placebo combined with exercise trainingCombination product
12 weeks of placebo (alike-looking cellulose-based capsules) combined with aerobic (30min of moderate-intensity walking) and resistance (30 min of whole-body workout) exercise training 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| (-)-Epicatechin combined with exercise | Active comparator | 12 weeks of daily cocoa (2 capsules/d containing 450 mg cocoa flavanols/d, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week Receives: Combination Product: (-)-Epicatechin-rich cocoa supplementation combined with exercise training |
| Placebo combined with exercise | Placebo comparator | 12 weeks of placebo (alike-looking cellulose-based capsules) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week Receives: Combination Product: Placebo combined with exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk test
We will assess exercise capacity of participants using the 6-min walk test, a safe and reliable test of aerobic endurance in older persons. This test has strong reproducibility, with intra-subject coefficients of variation averaging < 10%, and has a modest correlation with peak VO2peak. Participants will be asked to walk as far and fast as possible for 6-min on a 60 m distance making u-turns at 60m and start line cones.
Measured: At the baseline, 6-week, and 12-week follow-up visits.
Secondary outcomes (1)
Biodex test
Maximal strength (peak torque) of the knee flexors and extensors of the dominant limb will be assessed by a dynamometer (Biodex Medical Systems, New York, NY) as published previously. Based on our long-standing experience in performing muscle strength Biodex tests, these tests are reliable in moderately functioning older adults and are well-tolerated.
Measured: At the baseline, 6-week, and 12-week follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start21 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility DisabilityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert T Mankowski, University of Alabama at Birmingham
- Investigators
- Robert T Mankowski, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161726
- Sponsor's protocol ID
- IRB-300015048
- Other IDs
- 1R21AG092916-01A1
- Acronym
- COMET
- Status last verified
- May 2026
- First submitted
- 2 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may not be shared due to privacy concerns, the risk of re-identification in a small cohort, and the absence of participant consent for external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial
- ClinicalTrials.gov ID
- NCT07161726
- Acronym / sponsor ID
- COMET / IRB-300015048
- Conditions
- Mobility Disability
- Keywords
- Cocoa, Exercise, Mobility, Older adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
The purpose of the study is to see if regular exercise when combined with a cocoa supplement will improve physical performance and muscle strength compared to regular exercise alone.
Detailed description
Diminished mitochondrial function, excessive production of reactive oxygen species (ROS) and mitochondrial DNA (mtDNA) damage are key contributors to age-related physical capacity and muscle strength decline. Adaptation to aerobic and strength exercise training is currently one of the most effective ways to preserve physical performance and muscle strength in older adults. Aerobic and resistance exercise training improves mitochondrial function and stabilizes production of ROS, which contribute to aerobic capacity as well as strength improvements. However, obtaining optimal effects of exercise training may be limited by heterogeneity in the responsiveness due to biological barriers in skeletal muscle energy production, regardless of the adherence. Therefore, there is an unmet need for combining non-pharmacologic therapies with exercise training to "unlock" its full energetic potential to more effectively improve physical performance and muscle strength in older adults at risk of mobility disability. (-)-Epicatechin, a flavanol and a major ingredient present in cocoa, improved survival, muscle mitochondrial function and reduced excess ROS in mice. Supplementation with (-)-epicatechin-rich cocoa improved walking performance and muscle strength in older adults. Combination of (-)-epicatechin with exercise further improved mitochondrial function and reduced muscle fatigue in mice. We hypothesize that the combination of (-)-epicatechin-rich cocoa with structured aerobic and resistance exercise training will be more effective than exercise alone in improving physical performance and muscle strength by improved mitochondrial function and reduced ROS production in moderately functioning older adults. Our proposed pilot trial will test a 3-month exercise training intervention to collect preliminary data on walking performance, muscle strength and muscle size in 36 moderately functioning (slow walking speed <1m/s) older adults (>55 years old) without major comorbidities. The participants will be randomized to 12-week of daily (-)-epicatechin-rich cocoa (2 capsules/d containing 450 mg cocoa flavanols/day, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week (Epi+Ex, n=18) or the same exercise training regimen combined with cellulose-based blind (PL+Ex, n=18). Our primary outcome is walking distance measured by the 6-minute walk test. The lower-limb muscle strength and size measured by the Biodex test will be our secondary outcome. We will explore the potential mechanism of the hypothesized effect of Epi+Ex on walking performance and muscle strength by measuring mitochondrial biogenesis, mitochondrial DNA damage, ROS production and antioxidant enzyme activity in the vastus lateralis biopsies at baseline and 12-week follow-up. The objective of this exploratory/developmental proposal is to gather preliminary data on the efficacy and explore the mechanism of the Epi-Ex intervention to support the future Phase II clinical trial testing (-)-epicatechin-rich cocoa flavanols for exercise training optimization in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (-)-Epicatechin combined with exercise | Active comparator | Combination Product: (-)-Epicatechin-rich cocoa supplementation combined with exercise training12 weeks of daily cocoa (2 capsules/d containing 450 mg cocoa flavanols/d, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week |
| Placebo combined with exercise | Placebo comparator | Combination Product: Placebo combined with exercise training12 weeks of placebo (alike-looking cellulose-based capsules) combined with aerobic (30min of moderate-intensity walking) and resistance (25 min of whole-body workout) exercise training 3 times a week |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55 years and older
- Slow walking speed of < 1m/s
- Willingness to be randomized to either treatment group
- Willingness to participate in all study procedures (muscle biopsy will be optional)
Key exclusion criteria (16 listed)
- Failure to provide informed consent;
- Regular consumption of flavanol and/or cocoa supplements
- Current involvement in supervised rehabilitation/exercise training program
- Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines [17]
- Daytime average of systolic blood pressure ≥ 180/100mm Hg.
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 |
|---|---|---|
| (-)-Epicatechin-rich cocoa supplementation combined with exercise training12 weeks of daily cocoa (2 capsules/d containing 450 mg cocoa flavanols/d, including 80 mg of (-)-epicatechin) combined with aerobic (30min of moderate-intensity walking) and resistance (30 min of whole-body workout) exercise training 3 times a week | Combination product | (-)-Epicatechin combined with exercise |
| Placebo combined with exercise training12 weeks of placebo (alike-looking cellulose-based capsules) combined with aerobic (30min of moderate-intensity walking) and resistance (30 min of whole-body workout) exercise training 3 times a week | Combination product | Placebo combined with exercise |
Primary outcome
6-min walk test
Time frame: At the baseline, 6-week, and 12-week follow-up visits.
We will assess exercise capacity of participants using the 6-min walk test, a safe and reliable test of aerobic endurance in older persons. This test has strong reproducibility, with intra-subject coefficients of variation averaging < 10%, and has a modest correlation with peak VO2peak. Participants will be asked to walk as far and fast as possible for 6-min on a 60 m distance making u-turns at 60m and start line cones.
1 secondary outcome
Biodex test
Time frame: At the baseline, 6-week, and 12-week follow-up visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may not be shared due to privacy concerns, the risk of re-identification in a small cohort, and the absence of participant consent for external data sharing.
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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.
Robert T Mankowski, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing (-)-Epicatechin-rich cocoa supplementation combined with exercise training in people with Mobility Disability, run by University of Alabama at Birmingham 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 4 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert T Mankowski, PhD (205-996-3006, rmankowski@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test (time frame: At the baseline, 6-week, and 12-week follow-up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.