The subject will consume simvastatin (40mg) and placebo once daily for 3 months.

The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.

Statin Intolerance

Epicatechin is a compound found naturally in dark chocolate.

Pure epicatechin capsules (50mg)

A cholesterol-lowering medication that blocks the production of cholesterol.

Simvastatin (40mg)

A substance that has no therapeutic effect and will act as a control.

Placebo

University of California, San Diego

Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity

Effects of Epicatechin on Patients With Statin-induced Mitochondrial Dysfunction and Impaired Exercise Capacity

Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.

Skeletal muscle biopsies will be examined by electron microscopy to determine change in skeletal muscle structure. Western blots will be done to look for changes in protein levels.

Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function.

Pam Taub, MD

Associate Professor of Medicine

American Heart Association

Cardiovascular Disease

Cancer

2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Cocoa extract

Multivitamin

Cocoa extract placebo

Multivitamin placebo

Brigham and Women's Hospital

Fred Hutchinson Cancer Research Center

COcoa Supplement and Multivitamin Outcomes Study

CVD events include myocardial infarction, stroke, coronary revascularization procedures, and cardiovascular deaths. CVD events are confirmed by review of discharge summaries, ECG's, laboratory reports, test reports, and death certificates.

Diagnoses of invasive cancer are confirmed by review of discharge summaries, pathology reports, operative reports, and diagnostic or treatment procedure reports, including both inpatient and outpatient procedures.

Internet-based neuropsychological testing battery, including tests of novel object recognition, spatial learning, attention, inhibition, and executive control; face-to-face and computerized assessments of verbal memory, psychomotor speed, and executive function, working memory and organization; concentration and processing speed; visual recall; oral reading; receptive vocabulary; cognitive flexibility; attention; inhibitory control

epicatechin/stroke

Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity

COcoa Supplement and Multivitamin Outcomes Study

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