Clinical Trials Directory

Trials / Completed

CompletedNCT01681394

Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression

Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Technological Centre of Nutrition and Health, Spain · Academic / Other
Sex
Male
Age
20 Years – 35 Years
Healthy volunteers
Accepted

Summary

It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.

Detailed description

This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPolyphenol-rich cocoa extract250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
DIETARY_SUPPLEMENTChocolate cream

Timeline

Start date
2012-06-01
Primary completion
2012-12-01
Completion
2013-02-01
First posted
2012-09-07
Last updated
2013-07-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01681394. Inclusion in this directory is not an endorsement.