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The Effect of Cocoa Flavonoids on Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
MasterFoods
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00125866
First received: July 29, 2005
Last updated: April 16, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Behavioral: Flavonoid rich or flavonoid depleted chocolate drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Difference in mean 24 hour ambulatory blood pressure

Secondary Outcome Measures:
  • Difference in cholesterol
  • Difference in glucose
  • Difference in insulin
  • Difference in echocardiogram
  • Difference in pulse wave velocity

Estimated Enrollment: 50
Study Start Date: September 2005
Study Completion Date: January 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125866

Locations
United Kingdom
Imperial College London
Paddington, London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
MasterFoods
Investigators
Principal Investigator: Neil R Poulter Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125866     History of Changes
Other Study ID Numbers: NPSW01
Study First Received: July 29, 2005
Last Updated: April 16, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
randomised double blind trial
blood pressure
cocoa flavonoids

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013