Recruiting
Phase 1
Phase 2

Exercise & Cocoa

Sponsor:

University of Alabama at Birmingham

Code:

NCT07161726

Conditions

Mobility Disability

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

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

Placebo combined with exercise training

Study Details

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

Study ID

NCT07161726

Start date

Apr 21, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: (-)-Epicatechin combined with exercise

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

placebo comparator: Placebo combined with exercise

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

Interventions

(-)-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

Placebo 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

Primary outcome measure

  • 6-min walk test [ Time Frame: At the baseline, 6-week, and 12-week follow-up visits. ]

Central Contacts and Locations

Central contacts

Robert T Mankowski, PhD

205-996-3006rmankowski@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Cocoa
  • Exercise
  • Mobility
  • Older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-08.