The Effect of Cocoa Flavonoids on Blood Pressure - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 29, 2005

Last Updated Date

April 16, 2007

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

Difference in mean 24 hour ambulatory blood pressure

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00125866 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Difference in cholesterol
Difference in glucose
Difference in insulin
Difference in echocardiogram
Difference in pulse wave velocity

Original Secondary Outcome Measures ^†

Difference in cholesterol
Difference in glucose
Difference in insulin
Difference in echocardiogram
Difference in pulse wave velocity.

Descriptive Information

Brief Title ^†

The Effect of Cocoa Flavonoids on Blood Pressure

Official Title ^†

The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure

Brief Summary

The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.

Detailed Description

Flavonoids are natural substances found in fruits and vegetables, tea and red wine. The investigators know that people who eat a diet rich in these foods are less likely to have heart disease. This, in part, may be due to the blood pressure lowering effect of flavonoids. Cocoa beans are a rich natural source of flavonoids. Unfortunately when cocoa is made into chocolate most of the flavonoids are destroyed. The aim of this study is to find out the effect of cocoa flavonoids on blood pressure after 12 weeks of daily consumption of a specially prepared chocolate drink that is rich in flavonoids.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Hypertension

Intervention ^†

Behavioral: Flavonoid rich or flavonoid depleted chocolate drink

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Males or females of any age.
Diagnosis of hypertension and on antihypertensive treatment.
Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (<150/90mmHg).

Exclusion Criteria:

Participation in another clinical trial.
Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125866

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Imperial College London

Collaborators ^††

Masterfoods

Investigators ^†

Principal Investigator:

Neil R Poulter

Imperial College London

Information Provided By

Imperial College London

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.