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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.
Must not have
Non-English speaking
Six-minute walk distance of <500 feet or >1600 feet.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to six-month follow-up
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 years old or older.
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I have been diagnosed with peripheral artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I can walk less than 500 feet or more than 1600 feet in six minutes.
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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.
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My vision problems make it hard for me to walk.
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My walking is limited by a condition that is not related to leg artery disease.
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I have a current ulcer on the bottom of my foot.
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I am scheduled for major surgery or heart/leg artery treatment in the next 8 months.
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I have had an amputation above or below the knee.
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I have not had major surgery or significant heart-related procedures in the last 3 months.
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I use a wheelchair or walker to move around.
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I have severe blockage in my leg arteries causing pain and ulcers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to six-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to six-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Six-month change in six-minute walk distance
Secondary study objectives
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 more
Other study objectives
Association of calf perfusion with baseline gut microbial diversity with response to cocoa flavanols
Association of calf perfusion with six-month change in gut microbial composition
Association of metabolomic profiles with improved calf perfusion
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,652 Previous Clinical Trials
961,325 Total Patients Enrolled
28 Trials studying Peripheral Arterial Disease
4,884 Patients Enrolled for Peripheral Arterial Disease
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,667 Total Patients Enrolled
22 Trials studying Peripheral Arterial Disease
24,405 Patients Enrolled for Peripheral Arterial Disease
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,768 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
1,096 Patients Enrolled for Peripheral Arterial Disease
University of ChicagoOTHER
1,062 Previous Clinical Trials
839,944 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
1,746 Patients Enrolled for Peripheral Arterial Disease
Mary McDermott, MDPrincipal InvestigatorNorthwestern University
11 Previous Clinical Trials
1,694 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
1,694 Patients Enrolled for Peripheral Arterial Disease

Media Library

Cocoa Flavanols (Flavanols) Clinical Trial Eligibility Overview. Trial Name: NCT04794530 — Phase 3
Peripheral Arterial Disease Research Study Groups: cocoa flavanols, placebo
Peripheral Arterial Disease Clinical Trial 2023: Cocoa Flavanols Highlights & Side Effects. Trial Name: NCT04794530 — Phase 3
Cocoa Flavanols (Flavanols) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794530 — Phase 3
~56 spots leftby May 2026
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