A Phase 1 interventional study of Chocolate and Chocolate in Cardioprotection, sponsored by Griffin Hospital. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Griffin Hospital · Phase 1, Interventional, and Prevention
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.
Griffin Hospital is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
acute phase, solid dark chocolate, placebo
Other: Chocolate
acute phase, sugared cocoa, sugar-free cocoa, placebo
Other: Chocolate
sustained phase, sugared cocoa, sugar-free cocoa, placebo
Other: Chocolate
74 grams of single dose solid dark chocolate versus placebo
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
22 grams of sugared cocoa, sugar-free cocoa, \& placebo given for six weeks
Endothelial Function(acute & sustained phase)
Time frame: Single dose(acute phase), 6 weeks (sustained phase)
Blood Pressure(acute and sustained phase), lipid profile(sustained), LDL oxidation(sustained), lipid hydroperoxide(sustained), CRP(sustained), blood glucose(sustained), body weight(sustained), waist circumference(sustained), endothelin(sustained)
Time frame: Single dose(acute phase), 6 weeks(sustained phase)
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Griffin Hospital