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Cocoa and Endothelial Function in Adults With Elevated BMI

NCT00538083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Cardioprotection

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • David L Katz, MD · Yale-Griffin Prevention Research Center

  • Zubaida Faridi, MPH · Yale-Griffin Prevention Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Completion
2006-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538083 on ClinicalTrials.gov