Actively Recruiting
The COCOA-PAD II Trial
Led by Northwestern University · Updated on 2025-05-15
190
Participants Needed
3
Research Sites
271 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Actigraph-measured physical activity, brachial artery flow-mediated dilation (FMD), gastrocnemius muscle biopsy measures of endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, gastrocnemius muscle perfusion (measured by magnetic resonance imaging (MRI)) and gastrocnemius muscle characteristics (measured by muscle biopsy). To achieve the specific aims, the study will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for six months.
CONDITIONS
Official Title
The COCOA-PAD II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 and older
- Diagnosis of peripheral artery disease (PAD) defined by one of the following: ankle brachial index (ABI) of 0.90 or less at baseline; vascular lab evidence such as toe brachial pressure less than 0.70 or ABI between 0.90 and 1.00 with a 20% or greater drop after heel-rise test; or angiographic evidence showing at least 70% artery narrowing in the legs.
You will not qualify if you...
- Above- or below-knee amputation
- Critical limb ischemia
- Wheelchair confinement or requiring a walker to ambulate
- Walking limited by symptoms other than PAD
- Current foot ulcer on bottom of foot
- Failure to complete the one-week study run-in
- Planned major surgery or revascularization in next eight months
- Major surgery, revascularization, or major cardiovascular event in past three months
- Major medical illnesses including lung disease requiring oxygen, Parkinson's disease, life-threatening illness with life expectancy under eight months, or cancer needing treatment in past two years (early stage cancer with excellent prognosis may qualify; night-only oxygen use may qualify)
- Mini-Mental Status Examination (MMSE) score under 23
- Allergy to study intervention
- Use of cocoa supplements in past three months, unwillingness to avoid cocoa supplements, or regular consumption of dark chocolate exceeding specified amounts
- Non-English speaking
- Participation in or completion of a clinical trial in past three months (with specific exceptions for stem cell or gene therapy)
- Visual impairment limiting walking ability
- Six-minute walk distance less than 500 feet or greater than 1600 feet
- Participation in supervised treadmill exercise program in past three months
- Unable to tolerate caffeine
- Investigator discretion regarding safety or suitability for the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Mary McDermott, MD
CONTACT
K
Kathryn Domanchuk, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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