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

ConditionMobility Disability

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age55+

SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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]

Trial design

Design model

Parallel

Treatments tested in this trial

(-)-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
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

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: (-)-Epicatechin combined with exerciseActive comparator 1 intervention

Group B: Placebo combined with exercisePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Aging (NIA)