NCT00538083

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

First QC Date

September 28, 2007

Last Update Submit

March 25, 2020

Conditions

Cardioprotection

Keywords

CocoaOverweight adultsEndothelial functionBlood pressureCardiovascular disease riskDark chocolateSugar

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function(acute & sustained phase)

    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)

    Single dose(acute phase), 6 weeks(sustained phase)

Study Arms (3)

1, 2

EXPERIMENTAL

acute phase, solid dark chocolate, placebo

Other: Chocolate

3, 4, 5

EXPERIMENTAL

acute phase, sugared cocoa, sugar-free cocoa, placebo

Other: Chocolate

6, 7, 8

EXPERIMENTAL

sustained phase, sugared cocoa, sugar-free cocoa, placebo

Other: Chocolate

Interventions

ChocolateOTHER

74 grams of single dose solid dark chocolate versus placebo

1, 2

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Interventions

Chocolate

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • David L Katz, MD

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

  • Zubaida Faridi, MPH

    Yale-Griffin Prevention Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 2, 2007

Study Start

August 1, 2005

Study Completion

May 1, 2006

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)