The Effects of Alkalised Cocoa on Human Vascular Function

Study Overview
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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

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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Processed High-flavanol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavanol, Cocoa, Vascular function, Absorption, Metabolism, Alkalisation