The Effects of Alkalised Cocoa on Human Vascular Function

Sponsor

University of Reading (Other)

Overall Status

Completed

CT.gov ID

NCT01312584

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cardiovascular Disease	Dietary Supplement: Processed High-flavanol	N/A

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 Design

Study Type:

Interventional

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 :

Jun 1, 2010

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa. [change in Flow Mediated Dilation response between baseline and 2h]
Flow Mediated Dilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

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