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The Effect of Cocoa Flavonoids on Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125866
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
MasterFoods
Information provided by:
Imperial College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Flavonoid rich or flavonoid depleted chocolate drink Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure
Study Start Date : September 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Difference in mean 24 hour ambulatory blood pressure

Secondary Outcome Measures :
  1. Difference in cholesterol
  2. Difference in glucose
  3. Difference in insulin
  4. Difference in echocardiogram
  5. Difference in pulse wave velocity

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125866


Locations
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United Kingdom
Imperial College London
Paddington, London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
MasterFoods
Investigators
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Principal Investigator: Neil R Poulter Imperial College London
More Information
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ClinicalTrials.gov Identifier: NCT00125866    
Other Study ID Numbers: NPSW01
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: April 2007
Keywords provided by Imperial College London:
randomised double blind trial
blood pressure
cocoa flavonoids
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases