Cocoa and Endothelial Function in Adults With Elevated BMI | NCT00538083

Studies
Cocoa and Endothelial Function in Adults With Elevated BMI

NCT00538083

Sponsor

Griffin Hospital

Status

Completed

Last Update Posted

Mar 26, 2020Actual

Enrollment

45Actual

Phase

Phase 1

Conditions

Cardioprotection

Interventions

Chocolate
Chocolate
Chocolate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

May 2006Actual

First Submitted Date

Sep 28, 2007

First Submission Date that Met QC Criteria

Sep 28, 2007

First Posted Date

Oct 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2020

Last Update Posted Date

Mar 26, 2020Actual

Name	Class
Centers for Disease Control and Prevention	FED
The Hershey Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Chocolate	Other	74 grams of single dose solid dark chocolate versus placebo	1, 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David L Katz, MD	Yale-Griffin Prevention Research Center	Principal Investigator
Zubaida Faridi, MPH	Yale-Griffin Prevention Research Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Griffin Hospital		Derby	Connecticut	06418	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000069956	Chocolate

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided