Cocoa and Endothelial Function in Adults With Elevated BMI (Chocolate)
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|ClinicalTrials.gov Identifier: NCT00538083|
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : October 2, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardioprotection||Other: Chocolate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Dark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-Over Trial|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||May 2006|
Experimental: 1, 2
acute phase, solid dark chocolate, placebo
74 grams of single dose solid dark chocolate versus placebo
Experimental: 3, 4, 5
acute phase, sugared cocoa, sugar-free cocoa, placebo
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
Experimental: 6, 7, 8
sustained phase, sugared cocoa, sugar-free cocoa, 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538083
|United States, Connecticut|
|Derby, Connecticut, United States, 06418|
|Principal Investigator:||David L Katz, MD||Yale-Griffin Prevention Research Center|
|Study Director:||Zubaida Faridi, MPH||Yale-Griffin Prevention Research Center|