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

NCT07161726 | Not Yet Recruiting Phase 1

• 2 other identifiers: IRB-3000150481R21AG092916-01A1
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mobility Disability

Keywords

Cocoa; Exercise; Mobility; Older adults

Outcome Measures

Primary Outcomes (1)

• 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.

  At the baseline, 6-week, and 12-week follow-up visits.

Secondary Outcomes (1)

• Biodex test

  At the baseline, 6-week, and 12-week follow-up visits.

Study Arms (2)

(-)-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

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

Combination Product: Placebo combined with exercise training

Interventions

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

(-)-Epicatechin combined with exercise

Placebo combined with exercise training COMBINATION_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

Placebo combined with exercise

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robert T Mankowski, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert T Mankowski, PhD

CONTACT

205-996-3006; rmankowski@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02