Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Function
- Sponsor
- Technological Centre of Nutrition and Health, Spain
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Gene expression changes in PBMCs (using a microarray)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.
Exclusion Criteria
- •Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
- •Regular medication
- •Consumption of medication during the last week
- •Following a weight-loss diet
- •Vegetarians
- •Abnormal glucose levels
- •Cardiovascular disease
- •Gastrointestinal disease
Outcomes
Primary Outcomes
Gene expression changes in PBMCs (using a microarray)
Time Frame: 0-6 hours
Secondary Outcomes
- Blood pressure(0-2-3-6 hours)
- Endothelial function (assessed by ischemic reactive hyperemia)(0-2-3-6 hours)
- Plasma levels of procyanidins metabolites(0-6 hours)