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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Function, Gene Expression

Intervention / Treatment
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* Dietary Supplement: Polyphenol-rich cocoa extract
* Dietary Supplement: Chocolate cream


Participation Criteria
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Eligibility Criteria
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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 Smokers Regular medication Consumption of medication during the last week Following a weight-loss diet Vegetarians Abnormal glucose levels Diabetes Cardiovascular disease Gastrointestinal disease Anemia Allergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Product 1<br>250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols) | Dietary Supplement: Polyphenol-rich cocoa extract<br>* 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)<br>|
| Placebo Comparator: Control product<br>250 g of chocolate cream | Dietary Supplement: Chocolate cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression changes in PBMCs (using a microarray) |  | 0-6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |