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.
Description
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.
Status: Completed (Phase 1). Started on August 1st, 2005. Ended on May 1st, 2006.
Enrollment: 45 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Single Blind (Investigator)
- Placebo Control
- Crossover Assignment
- Efficacy Study
Conditions:
Interventions:
- Other: Chocolate
- Other: Chocolate
- Other: Chocolate
Eligibility
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
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)
- Gender
Both
- Mininum Age
30 Years
- Maximum Age
75 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: Griffin Hospital
Authority: United States: Institutional Review Board
Locations
-
Griffin Hospital
Derby
Connecticut
06418
United States
Officials
David L Katz, MD (Principal Investigator, Yale-Griffin Prevention Research Center)
Zubaida Faridi, MPH (Study Director, Yale-Griffin Prevention Research Center)
Sponsors
Griffin Hospital (Lead Sponsor)
Centers for Disease Control and Prevention (Collaborator)
The Hershey Company (Collaborator)
References
None.
Links
None.
- Date Verified
- September 1st, 2007
- First Received
- September 28th, 2007
- Last Changed
- September 28th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.
The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.