36 Participants NeededMy employer runs this trial

Cocoa Supplementation + Exercise for Mobility Disability

(COMET Trial)

RT
Overseen ByRobert T Mankowski, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Alabama at Birmingham

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cocoa supplement, combined with regular exercise, can enhance physical performance and muscle strength more effectively than exercise alone. Participants will take a special cocoa compound, (-)-Epicatechin, while engaging in both aerobic (walking) and resistance exercises. Individuals who have noticed a slower walking pace and are open to trying either the cocoa supplement or a placebo may be suitable candidates. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking health advancements.

Will I have to stop taking my current medications?

The trial requires participants to stop taking blood thinners like baby aspirin. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cocoa supplements, particularly those rich in cocoa flavanols, have been studied for their safety and health benefits. One study with older adults found that daily consumption of natural cocoa for 12 weeks improved muscle mass without significant side effects. Another study discovered that cocoa flavanols could enhance exercise ability and heart health, again without major negative effects.

These findings suggest that cocoa supplements are generally safe, especially as early clinical trials focus on safety. While guarantees cannot be made, current evidence indicates a low risk of side effects from cocoa supplements in these studies.12345

Why do researchers think this study treatment might be promising?

Most treatments for mobility disability focus on physical therapy or medication to manage symptoms. However, this trial is exploring a unique combination of cocoa flavanols, specifically (-)-epicatechin, with exercise. Researchers are excited about the potential of cocoa flavanols because they may enhance blood flow and muscle function, which could improve mobility more effectively than traditional methods. This approach also emphasizes a natural supplement, which might offer a safer alternative with fewer side effects compared to conventional drugs.

What evidence suggests that cocoa supplementation combined with exercise might be an effective treatment for mobility disability?

Research has shown that cocoa supplements might enhance exercise performance and mobility. In this trial, one group will receive cocoa supplements with exercise, while another group will receive a placebo with exercise. One study found that participants who took cocoa walked 42.6 meters farther in six minutes, indicating improved walking ability. Another study found that cocoa flavanols increased exercise capacity in healthy older adults. Additionally, cocoa's flavanols benefit heart health and might improve muscle mass and movement. These findings suggest that cocoa supplements could enhance physical performance, especially when combined with regular exercise.12456

Who Is on the Research Team?

RT

Robert T Mankowski, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 55 and older who have slow walking speed (less than 1 meter per second) and are willing to join either group and take part in all study activities. Muscle biopsy is optional.

Inclusion Criteria

I am 55 years old or older.
I walk slower than 1 meter per second.
I am willing to be assigned to any treatment group by chance.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily (-)-epicatechin-rich cocoa or placebo combined with aerobic and resistance exercise training

12 weeks
3 times a week for exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Follow-up visits at baseline, 6-week, and 12-week

What Are the Treatments Tested in This Trial?

Interventions

  • Cocoa Supplement

Trial Overview

The study compares the effects of a cocoa supplement rich in (-)-epicatechin plus exercise training versus a placebo plus exercise training on improving physical performance and muscle strength in older adults.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: (-)-Epicatechin combined with exerciseActive Control1 Intervention
Group II: Placebo combined with exercisePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Effects of cocoa extract supplementation on physical ... - PMC

Our study in ambulatory older men and women with a mean age of 69.7 yr found that, compared to placebo, cocoa extract supplementation did not affect 2-yr ...

Cocoa to Improve Walking Performance in Older People ...

Adjusting for smoking, race, and body mass index, cocoa improved 6-minute walk distance at 6-month follow-up by 42.6 m ([90% CI, +22.2 to +∞] P= ...

Cocoa flavanols improve peakVO 2 and exercise capacity in a ...

Cocoa flavanols improve peakVO2 and exercise capacity in a randomized double blinded clinical trial in healthy elderly people†.

Effects of cocoa extract supplementation and multivitamin ...

Some studies suggest that flavanols, which are present in large quantities in cocoa, may have beneficial effects on bone. Multivitamin/multimineral (MVM) ...

The Cocoa-Pad Pilot Randomized Clinical Trial - PMC

In a phase II randomized clinical trial, to assess whether six months of cocoa improved walking performance in people with PAD, compared to placebo.

The role of cocoa flavanols in modulating peripheral and ...

Cocoa flavanols (CFs) are polyphenolic molecules with proposed cardioprotective effects. Whilst extensive evidence supports their ability to ...