N/A
Completed N=44
Cocoa to Improve Walking Performance in Peripheral Artery Disease
Source: ClinicalTrials.gov NCT02876887 ↗Enrolled (actual)
44
Serious AEs
20.5%
Results posted
Aug 2020
Primary outcomePrimary: Change From Baseline in Six-minute Walk Distance — 18.4; -24.2; 15.1; -2.9 meters
Summary
The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months improves walking performance in individuals with peripheral artery disease compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Six-minute Walk Distance |
18.4; -24.2; 15.1; -2.9 | — |
| SECONDARY Change From Baseline in Maximal and Pain-free Treadmill Walking Time |
-0.03; 0.28; -0.07; 0.39 | — |
| SECONDARY Change in Baseline From Brachial Artery Flow-mediated Dilation: Change in Brachial Artery Diameter |
-0.65; 0.63; 0.04; -0.59 | — |
| SECONDARY Change From Baseline Accelerometer-measured Physical Activity |
-1919; -8981 | — |
| SECONDARY Change in Baseline Calf Skeletal Muscle Measures: Abundance of PGC1α, Myostatin and Follistatin |
0.09; 0.04; 0.26; 0.15; -0.03; 0.09 | — |
| SECONDARY Change in Baseline MRI-Measured Calf Skeletal Muscle Perfusion |
0.10; -0.32 | — |
| SECONDARY Change in Baseline Calf Skeletal Muscle Measures: Citrate Synthase and COX Activity |
-0.25; -1.10; -4.6; -90 | — |
Eligibility Criteria
Inclusion Criteria
- All participants will be age 60 and older.
- All participants will have PAD. PAD will be defined as follows. First, an ABI 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible.
Exclusion Criteria
- Above- or below-knee amputation.
- Critical limb ischemia.
- Wheelchair-bound or requiring a cane or walker to ambulate.
- Walking is limited by a symptom other than PAD.
- Baseline six-minute walk value of 1, 600 feet
- Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months.
- Planned revascularization or major surgery during the next six months.
- Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.]
- Mini-Mental Status Examination (MMSE) score < 23 or dementia.
- Unwilling to attend three visits in one week for final outcome measures.
- Allergy to chocolate.
- Unwilling or unable to consume products manufactured on the same equipment that processes peanuts, tree nuts, egg, wheat, soy, and milk.
- Use of cocoa-containing dietary supplements.
- Unwilling to give up major dietary sources of epicatechin during the study.
- Symptoms of heart failure or angina that limit walking activity more than ischemic leg symptoms, increase in angina, or angia at rest (i.e. unstable angina).
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
- Non-English speaking, a visual impairment that limits walking ability.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Data sourced from ClinicalTrials.gov (NCT02876887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.