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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

Tracking Information
First Submitted Date  ICMJE July 29, 2005
First Posted Date  ICMJE August 2, 2005
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2005)
Difference in mean 24 hour ambulatory blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2005)
  • Difference in cholesterol
  • Difference in glucose
  • Difference in insulin
  • Difference in echocardiogram
  • Difference in pulse wave velocity
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2005)
  • Difference in cholesterol
  • Difference in glucose
  • Difference in insulin
  • Difference in echocardiogram
  • Difference in pulse wave velocity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Cocoa Flavonoids on Blood Pressure
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Behavioral: Flavonoid rich or flavonoid depleted chocolate drink
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 29, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00125866
Other Study ID Numbers  ICMJE NPSW01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE MasterFoods
Investigators  ICMJE
Principal Investigator: Neil R Poulter Imperial College London
PRS Account Imperial College London
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP