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.
Phase:
Phase 3
Details
Lead Sponsor:
Northwestern University
Collaborators:
National Institute on Aging (NIA) University of Chicago University of Minnesota