The COCOA-PAD II Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT04794530
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cocoa flavanols — DRUG
    The cocoa flavanols intervention is manufactured by Mars Inc. Participants randomized to cocoa flavanols will take two capsules daily of cocoa flavanols. The two capsules of cocoa flavanols will contain approximately 500 mg of cocoa flavanols and appoximately 80 mg of (-)-epicatechin.
  • placebo — DRUG
    The placebo intervention will be manufactured by Mars Inc. and will appear identical to the cocoa flavanols intervention. Participants will take two capsules daily of placebo. The placebo will be a cellulose based capsule and will not contain cocoa flavanols or (-)-epicatechin.

Study Details

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.

Key Dates

Start date
Nov 19, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: cocoa flavanols
  • Placebo Comparator: placebo

Primary Outcome Measure

Six-month change in six-minute walk distance [ Time Frame: Baseline to six-month follow-up ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Mary McDermott, MD
[email protected]
312-503-6419
University of ChicagoChicagoIllinois60637
Tamar Polonsky, MD
[email protected]
312-608-0250
University of MinnesotaMinneapolisMinnesota55455
Diane Treat-Jacobson, PhD
[email protected]
612-624-7613

Find similar trials in Chicago, IL

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Northwestern University· Chicago, ILUniversity of Chicago· Chicago, ILUniversity of Minnesota· Minneapolis, MN

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