NCT07161726 Cocoa to Maximize Exercise Training in Older Adults - The COMET Trial
| NCT ID | NCT07161726 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Mobility Disability |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-04-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Robert T Mankowski, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT07161726 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Mobility Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07161726 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07161726 currently recruiting?
Yes, NCT07161726 is actively recruiting participants. Contact the research team at rmankowski@uabmc.edu for enrollment information.
Where is the NCT07161726 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT07161726 clinical trial?
NCT07161726 is sponsored by University of Alabama at Birmingham. The principal investigator is Robert T Mankowski, PhD at University of Alabama at Birmingham. The trial plans to enroll 36 participants.