Cocoa and Endothelial Function in Adults With Elevated BMI (NCT00538083) | Clinical Trial Compass
CompletedPhase 1
Cocoa and Endothelial Function in Adults With Elevated BMI
United States45 participantsStarted 2005-08
Plain-language summary
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.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion Criteria:
* Ages between 30 -75
* BMI between 25-35 kg/m2
* waist circumference above 88 cms. in women and 102 cms. in men
* non-smoker
* no strenuous exercise at least 8 hours prior to scanning
* to facilitate recruitment individuals with diagnosed hypertension or hyperlipidemia will be included provided that they have been stable on their medications for three months, and can refrain from taking their medication 12 hours prior to BARS testing.
Exclusion Criteria:
* Failure to meet inclusion criteria
* anticipated inability to complete study protocol for any reason
* current eating disorder
* diagnosed coronary artery disease
* diabetes
* sleep apnea
* current or impending pregnancy
* insulin or glucose sensitizing medication use, vasoactive medication or nutriceutical use (glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators)
* regular use of high dose vitamin E or C and unable to discontinue for duration of the study
* regular use of fiber supplements and unable to discontinue for duration of the study
* restricted diets by choice (i.e. vegan, Atkins diet etc)
* allergy to cocoa or chocolate.
What they're measuring
1
Endothelial Function(acute & sustained phase)
Timeframe: Single dose(acute phase), 6 weeks (sustained phase)