NCT02221791

Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Endothelial Dysfunction
• Bioavailability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pure Epicatechin	Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
DIETARY_SUPPLEMENT	High flavan-3-ol cocoa	Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
DIETARY_SUPPLEMENT	Placebo	Participants will consume 70g white chocolate + placebo capsules

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-08-20
• Last updated: 2014-10-15

Locations

1 site across 1 country: Netherlands