The Effects of Alkalised Cocoa on Human Vascular Function

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. Identifier: NCT01312584
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Information provided by:
University of Reading

Brief Summary:
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

Condition or disease Intervention/treatment
Cardiovascular Disease Dietary Supplement: Processed High-flavanol

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols
Study Start Date : June 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Arm Intervention/treatment
Placebo Comparator: Non alkalised High Flavanol
Non-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols
Dietary Supplement: Processed High-flavanol
Active Comparator: Alkalised high Flavanol
Alkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols
Dietary Supplement: Processed High-flavanol
Active Comparator: Alkalised Low Flavanol
Alkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols
Dietary Supplement: Processed High-flavanol

Primary Outcome Measures :
  1. In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa. [ Time Frame: change in Flow Mediated Dilation response between baseline and 2h ]
    Flow Mediated Dilation

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01312584

United Kingdom
University of Reading
Reading, Berkshire, United Kingdom
Sponsors and Collaborators
University of Reading
Principal Investigator: Jeremy Spencer, PhD University of Reading

Responsible Party: Dr Jeremy P E Spencer, University of Reading Identifier: NCT01312584     History of Changes
Other Study ID Numbers: UReading-2010-01
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: November 2010

Keywords provided by University of Reading:
Vascular function

Additional relevant MeSH terms:
Cardiovascular Diseases