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

Not Applicable

Completed

• Conditions: Cardiovascular Function; Gene Expression
• Interventions: Dietary Supplement: Chocolate cream; Dietary Supplement: Polyphenol-rich cocoa extract

• Registration Number: NCT01681394
• Lead Sponsor: Technological Centre of Nutrition and Health, Spain

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.

Exclusion Criteria

1. Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
2. Smokers
3. Regular medication
4. Consumption of medication during the last week
5. Following a weight-loss diet
6. Vegetarians
7. Abnormal glucose levels
8. Diabetes
9. Cardiovascular disease
10. Gastrointestinal disease
11. Anemia
12. Allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control product	Chocolate cream	250 g of chocolate cream
Product 1	Polyphenol-rich cocoa extract	250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)

Primary Outcome Measures

Name	Time	Method
Gene expression changes in PBMCs (using a microarray)	0-6 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Technological Center of Nutrition and Health (CTNS); 🇪🇸 Reus, Tarragona, Spain