The Effects of Alkalised Cocoa on Human Vascular Function

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312584

Enrollment

Registered

2011-03-10

Start date

2010-06-30

Completion date

2010-09-30

Last updated

2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Flavanol, Cocoa, Vascular function, Absorption, Metabolism, Alkalisation

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

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.

Interventions

DIETARY_SUPPLEMENTProcessed High-flavanol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026