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Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function — FLAVO2  

Endothelial Dysfunction Clinical Trial

Official title:
Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

Clinical Trial Summary

Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers of vascular function and insulin resistance although the results were less pronounced than the majority of chocolate intervention studies.

The food matrix of chocolate or other compounds present in chocolate could play a role in the bioavailability of flavonoids, resulting in these heightened improvements in vascular function.

In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid chocolate on markers of vascular function.

Clinical Trial Description

Twenty male participants between the ages of 40 and 80 will visit the university on three days, separated by a 2-week washout. During each visit the participants will, in random order, be allocated to one of the three interventions:

1. High flavan-3-ol chocolate (70g) plus placebo capsule;

2. White chocolate (70g) plus 100mg of epicatechin in capsule form;

3. White chocolate (70g) plus placebo capsule; Measurements of vascular function will be taken before, and 2 hours after consumption of the supplements. In order to determine flavonoid bioavailability, 24-hour urine samples will be collected and 7 blood samples will be taken over a period of 8 hours.

The primary study parameter is the percentage change in Flow-Mediated Dilation (FMD) as a result of a high-flavonoid cocoa or epicatechin challenge. Additional study parameters include plasma flavonoid and nitric oxide concentrations as well as pulse wave analysis parameters. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02221791
Study type Interventional
Source Wageningen University
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date October 2014
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