Cocoa with exercise to boost walking and strength in older adults
Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial
This study will test whether taking a cocoa supplement high in (-)-epicatechin together with regular aerobic and resistance exercise helps older adults with slow walking speed improve walking and muscle strength more than exercise alone.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07161726 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 1/2 study enrolls adults aged 55 and older with slow walking speed (<1.0 m/s) and compares structured aerobic plus resistance training combined with an (-)-epicatechin–rich cocoa supplement versus the same exercise program with a placebo. Participants follow supervised exercise sessions and undergo functional testing of walking performance and muscle strength, with optional muscle biopsy for mechanistic studies. The trial targets mitochondrial function and reactive oxygen species pathways as potential biological reasons some people do not fully respond to exercise alone. The study is single-site at the University of Alabama at Birmingham.
Who should consider this trial
Good fit: Ideal candidates are adults 55 years or older with slow walking speed (<1.0 m/s) who can participate in supervised aerobic and resistance training and agree to randomization and study procedures.
Not a fit: People already taking flavanol or cocoa supplements, currently enrolled in supervised exercise programs, or with medical contraindications to exercise (for example severe cardiac disease) are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding an (-)-epicatechin–rich cocoa supplement to exercise could produce greater improvements in walking speed and muscle strength than exercise by itself.
How similar studies have performed: Animal studies and small human studies have shown (-)-epicatechin–rich cocoa can improve mitochondrial function, walking performance, and strength, and combining it with exercise helped mice, but larger randomized trials in older adults remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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. * 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Robert T Mankowski, PhD — University of Alabama at Birmingham
- Study coordinator: Robert T Mankowski, PhD
- Email: rmankowski@uabmc.edu
- Phone: 205-996-3006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.