ChocolateDark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial
Chocolate
Prevention Study
Summary
Study start date: August 1, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location