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The Effects of Alkalised Cocoa on Human Vascular Function

This study has been completed.
Sponsor:
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT01312584
First received: March 9, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted

March 9, 2011
March 9, 2011
June 2010
September 2010   (final data collection date for primary outcome measure)
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa. [ Time Frame: change in Flow Mediated Dilation response between baseline and 2h ] [ Designated as safety issue: No ]
Flow Mediated Dilation
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Alkalised Cocoa on Human Vascular Function
The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols

The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa

A randomised, triple blind, cross-over design human intervention studies will be conducted in 10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism and vascular reactivity of cocoa flavanols. Participants will be requested to consume a standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and micronutrient content. Vascular measurements will be performed by using Flow Mediated Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine samples will be taken to measure the concentration of flavonoids from the cocoa drinks and markers of blood vessel function. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Cardiovascular Disease
Dietary Supplement: Processed High-flavanol
  • Placebo Comparator: Non alkalised High Flavanol
    Non-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols
    Intervention: Dietary Supplement: Processed High-flavanol
  • Active Comparator: Alkalised high Flavanol
    Alkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols
    Intervention: Dietary Supplement: Processed High-flavanol
  • Active Comparator: Alkalised Low Flavanol
    Alkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols
    Intervention: Dietary Supplement: Processed High-flavanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • signed consent form
  • age of 18-35 years inclusive
  • BMI between 18.5-30

Exclusion Criteria:

  • Blood pressure > 150/90 mmHg
  • Haemoglobin (anaemia marker) < 125 g/l
  • Gamma GT (liver enzymes) > 80 IU/l
  • Cholesterol > 6.5 mmol/l
  • Had suffered a myocardial infarction or stroke in the previous 12 months
  • Suffers from any reproductive disorder
  • Suffers from any blood-clotting disorder
  • Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
  • Any dietary restrictions or on a weight reducing diet
  • Drinking more than 21 units per week
  • On any lipid-modifying medication
  • On any blood pressure lowering medication
  • On any medication affecting blood clotting
  • Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
  • Regular or vigorous exercise (3 times/week, 20 minutes each session)
  • Smoking
Male
19 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01312584
UReading-2010-01
Yes
Dr Jeremy P E Spencer, University of Reading
University of Reading
Not Provided
Principal Investigator: Jeremy Spencer, PhD University of Reading
University of Reading
November 2010

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