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Flavanols
Cocoa Flavanols for Peripheral Arterial Disease (COCOA-PAD II Trial)
Phase 3
Recruiting
Led By Mary McDermott, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55 and older
Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to six-month follow-up
Awards & highlights
COCOA-PAD II Trial Summary
This trial will test whether cocoa flavanols can improve peripheral artery disease by measuring six-minute walk distance, 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).
Who is the study for?
The COCOA-PAD II Trial is for individuals aged 55 or older with peripheral artery disease (PAD), defined by specific diagnostic criteria. Excluded are those with severe cognitive impairment, current foot ulcers, recent major surgeries or cardiovascular events, certain allergies, and other serious health conditions that limit walking or life expectancy.Check my eligibility
What is being tested?
This trial investigates whether cocoa flavanols can improve walking distance over six months in PAD patients compared to a placebo. The study will enroll 190 participants who will be randomly assigned to receive either the cocoa flavanols or a placebo.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include mild discomforts related to cocoa consumption such as digestive issues and caffeine sensitivity.
COCOA-PAD II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
I have been diagnosed with peripheral artery disease.
COCOA-PAD II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to six-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to six-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Six-month change in six-minute walk distance
Secondary outcome measures
Six minute walk at two and four week follow-up after intervention completion.
Six-month change in Actigraph-measured physical activity
Six-month change in brachial artery flow-mediated dilation (FMD)
+3 moreOther outcome measures
Six-month change in plasma abundance of cocoa flavanols
COCOA-PAD II Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: cocoa flavanolsActive Control1 Intervention
Group II: placeboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,936 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,232 Patients Enrolled for Peripheral Arterial Disease
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,695 Total Patients Enrolled
20 Trials studying Peripheral Arterial Disease
16,405 Patients Enrolled for Peripheral Arterial Disease
University of MinnesotaOTHER
1,381 Previous Clinical Trials
1,588,585 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
1,101 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I haven't taken cocoa supplements or eaten dark chocolate regularly in the last 3 months.I can walk less than 500 feet or more than 1600 feet in six minutes.You have been in a monitored treadmill exercise program in the last three months.I do not have a severe illness that limits my life expectancy to under 8 months, except for early-stage cancer treated within the last 2 years with an excellent prognosis.You are allergic to the treatment being studied.Your Mini-Mental Status Examination (MMSE) score is less than 23.I am 55 years old or older.My vision problems make it hard for me to walk.I have not been in a clinical trial in the last 3 months, or it's been 6 months since my last stem cell or gene therapy.My walking is limited by a condition that is not related to leg artery disease.You did not complete the one-week study trial successfully.I have a current ulcer on the bottom of my foot.I have been diagnosed with peripheral artery disease.I am scheduled for major surgery or heart/leg artery treatment in the next 8 months.I have had an amputation above or below the knee.I have not had major surgery or significant heart-related procedures in the last 3 months.I use a wheelchair or walker to move around.I have severe blockage in my leg arteries causing pain and ulcers.You cannot handle caffeine.
Research Study Groups:
This trial has the following groups:- Group 1: cocoa flavanols
- Group 2: placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being given this drug as part of the trial?
"The information available on clinicaltrials.gov suggests that this trial is currently looking for volunteers. This research project was originally posted on November 19th, 2021 and has been updated as recently as June 16th, 2022. In total, 190 individuals are needed at a single location."
Answered by AI
Have any benefits of cocoa flavanols been officially recognized by the FDA?
"There is some efficacy data and multiple rounds of safety data, so our team at Power has estimated the cocoa flavanols to be a 3 on a scale from 1 to 3."
Answered by AI
Are investigators currently looking for more test subjects?
"Yes, this information is available on clinicaltrials.gov. The site shows that the study was posted on 11/19/2021 and was last updated on 6/16/2022."
Answered by AI
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