Cocoa and Endothelial Function in Adults With Elevated BMI (Chocolate)

March 25, 2020 updated by: Griffin Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Griffin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1, 2
acute phase, solid dark chocolate, placebo
Other: Chocolate
74 grams of single dose solid dark chocolate versus placebo
Other: Chocolate
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
Other: Chocolate
22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks
Experimental: 3, 4, 5
acute phase, sugared cocoa, sugar-free cocoa, placebo
Other: Chocolate
74 grams of single dose solid dark chocolate versus placebo
Other: Chocolate
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
Other: Chocolate
22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks
Experimental: 6, 7, 8
sustained phase, sugared cocoa, sugar-free cocoa, placebo
Other: Chocolate
74 grams of single dose solid dark chocolate versus placebo
Other: Chocolate
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
Other: Chocolate
22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial Function(acute & sustained phase)
Time Frame: Single dose(acute phase), 6 weeks (sustained phase)
Single dose(acute phase), 6 weeks (sustained phase)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Single dose(acute phase), 6 weeks(sustained phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Griffin Hospital

Collaborators

Centers for Disease Control and Prevention
The Hershey Company

Investigators

  • Principal Investigator: DAVID L KATZ, MD, Yale-Griffin Prevention Research Center
  • Study Director: Zubaida Faridi, MPH, Yale-Griffin Prevention Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2005-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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