The COCOA-PAD II Trial

Launched by NORTHWESTERN UNIVERSITY · Mar 10, 2021

Keywords

ClinConnect Summary

The COCOA-PAD II Trial is a research study aimed at understanding whether cocoa flavanols can help improve walking ability in older adults with peripheral artery disease (PAD). This study will involve 190 participants aged 55 and older, who will be randomly assigned to receive either cocoa flavanols or a placebo (a sugar pill that looks like the treatment but has no active ingredients) for six months. The main goal is to see if those taking cocoa flavanols can walk further in six minutes compared to those taking the placebo. Researchers will also look at other factors, such as overall physical activity and changes in blood flow to the muscles.

To participate, individuals must be 55 years or older and have PAD, which can be confirmed by specific tests. However, certain conditions, like having a severe walking impairment or recent major surgeries, may prevent participation. Participants can expect to take the assigned treatment daily and attend regular follow-up visits over the six months to track their progress. This study is currently recruiting, and it’s important for anyone interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 55 and older
• 2. Presence of peripheral artery disease (PAD). PAD will be defined as either:
• • 1. An ABI \<= 0.90 at baseline.
• • 2. Vascular lab evidence of PAD (such as a toe brachial pressure \< 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
• • 3. An ABI of \>0.90 and \<=1.00 who experience a a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.
• Exclusion Criteria:
• • 1. Above- or below-knee amputation
• • 2. Critical limb ischemia
• • 3. Wheelchair confinement or requiring a walker to ambulate
• • 4. Walking is limited by a symptom other than PAD
• • 5. Current foot ulcer on bottom of foot
• • 6. Failure to successfully complete the one-week study run-in
• • 7. Planned major surgery, coronary or leg revascularization during the next eight months
• • 8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
• • 9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than eight months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\]
• • 10. Mini-Mental Status Examination (MMSE) score \< 23
• • 11. Allergy to the study intervention
• • 12. Potential participants who have taken cocoa supplements in previous three months, are unwilling to avoid taking cocoa flavanol supplements, or are consuming dark chocolate regularly (i.e. approximately 1.5 ounces of dark chocolate more than three times per week, or more than 4.5 ounces per week).
• • 13. Non-English speaking
• • 14. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
• • 15. Visual impairment that limits walking ability
• • 16. Six-minute walk distance of \<500 feet or \>1600 feet.
• • 17. Participation in a supervised treadmill exercise program in previous three months
• • 18. Unable to tolerate caffeine
• • 19. 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