RecruitingPhase 1Phase 2NCT07161726

Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial


Sponsor

University of Alabama at Birmingham

Enrollment

36 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 Years

Inclusion Criteria4

  • 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 Criteria16

  • 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

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Interventions

COMBINATION_PRODUCT(-)-Epicatechin-rich cocoa supplementation combined with exercise training

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

COMBINATION_PRODUCTPlacebo combined with exercise training

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


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT07161726


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