The Effects of Alkalised Cocoa on Human Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Non alkalised High Flavanol

Non-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols

Group Type PLACEBO_COMPARATOR

Processed High-flavanol

Intervention Type DIETARY_SUPPLEMENT

Alkalised high Flavanol

Alkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols

Group Type ACTIVE_COMPARATOR

Processed High-flavanol

Intervention Type DIETARY_SUPPLEMENT

Alkalised Low Flavanol

Alkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols

Group Type ACTIVE_COMPARATOR

Processed High-flavanol

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Processed High-flavanol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes