The Effect of Cocoa Flavonoids on Blood Pressure

May 27, 2015 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London
      • Paddington, London, United Kingdom, W2 1PG
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in mean 24 hour ambulatory blood pressure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

MasterFoods

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (ESTIMATE)

August 2, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPSW01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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