The Effects of Alkalised Cocoa on Human Vascular Function

Cardiovascular Disease Clinical Trial

Official title:

The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312584
• Other study ID #: UReading-2010-01
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: March 9, 2011
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Processed High-flavanol

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa.	Flow Mediated Dilation	change in Flow Mediated Dilation response between baseline and 2h	No