Status:
NOT_YET_RECRUITING
Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Mobility Disability
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07161726
Start Date
December 15 2025
End Date
December 31 2027
Last Update
September 9 2025
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