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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
  Purpose

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 Intervention
Cardiovascular Disease
Dietary Supplement: Processed High-flavanol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312584

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

No publications provided

Responsible Party: Dr Jeremy P E Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT01312584     History of Changes
Other Study ID Numbers: UReading-2010-01
Study First Received: March 9, 2011
Last Updated: March 9, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
Flavanol
Cocoa
Vascular function
Absorption
Metabolism
Alkalisation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014