Cardiovascular Health Effects of Flavanol Rich Chocolate | NCT01308892

Studies
Cardiovascular Health Effects of Flavanol Rich Chocolate

NCT01308892

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Jun 17, 2011Estimated

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Endothelial Dysfunction

Interventions

High flavanol chocolate
Low flavanol chocolate
High fat challenge

Countries

Netherlands

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

Jun 2011

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

Jan 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Mar 3, 2011

First Posted Date

Mar 4, 2011Estimated

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

Jun 16, 2011

Last Update Posted Date

Jun 17, 2011Estimated

Name	Class
Top Institute Food and Nutrition	OTHER

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

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High flavaonol chocolate	Active Comparator		Dietary Supplement: High flavanol chocolate Dietary Supplement: High fat challenge
Low flavanol chocolate	Placebo Comparator		Dietary Supplement: Low flavanol chocolate Dietary Supplement: High fat challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High flavanol chocolate	Dietary Supplement	chocolate high in flavanols	High flavaonol chocolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure		0, 4wk
FMD		0, 4wk
PWA		0, 4wk

Secondary Outcomes

Measure	Description	Time Frame
leukocyte count and activation		0, 4wk
PBMC gene expression		0, 4wk
Markers of inflammation and ED

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
45-70 years old
BMI between 25 and 32 kg/m2

Exclusion Criteria:

Urine glucose concentrations outside normal ranges (> 0,25 g/l)
Fasting blood glucose < 7.0 mmol/L)
Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg
Blood Hb values below 8.4 mmol/L
Allergic to cow milk, dairy products or chocolate
Vegetarian
Tobacco smoker
Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 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
Michael Müller, Prof.Dr	Chair Department of human nutrition NMG group	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wageningen universiteit division of human		Wageningen	Gelderland	6703HD	Netherlands