Cardioprotection Clinical Trial
Official title:
Dark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial
Cardiovascular disease is the leading cause of death in the United States. Studies have shown
that obesity is an important risk factor for development of cardiovascular disease.
Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of
cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts
cardioprotective effects, which include increasing HDL levels, reduction in systolic BP,
inhibition of platelet aggregation/activity and activation of endothelial nitric oxide
synthase.
Proposed is a randomized controlled trial consisting of 4 phases designed to examine the
dose-response, and the acute and sustained effects of cocoa consumption on endothelial
function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI
25-35kg/m2.
Endothelial function has been used extensively to evaluate the acute and chronic effects of
foods and nutrients on cardiac risk and can provide a direct measurement of the effect of
cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35
kg/m2.
To our knowledge, our study is the first to examine the dose response effects of sugar free,
liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on
individuals with elevated BMI. Given the current epidemic of obesity in the United States;
its role as a risk factor in the development of cardiovascular disease; and the fact that
cardiovascular disease is the leading cause of mortality in this country, examination of the
cardio-protective effects of cocoa or dark chocolate in an at risk population is of
considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage
caused to the endothelium may lead to new dietary recommendations that may help curb the
prevalence of heart disease in the U.S.
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