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NCT Number: NCT00538083

Cocoa and Endothelial Function in Adults With Elevated BMI

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.

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Key information

Conditions

Cardioprotection

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Griffin Hospital

Derby, Connecticut, 06418, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chocolate

Other

74 grams of single dose solid dark chocolate versus placebo

Primary outcomes

  1. Endothelial Function(acute & sustained phase)

    Time frame: Single dose(acute phase), 6 weeks (sustained phase)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Griffin Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention
  • The Hershey Company

Registry information

Official study title

Dark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial

Acronym: Chocolate

Important dates

Study start
2005
Study completion
2006
First posted
Oct 2, 2007
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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