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

Technological Centre of Nutrition and Health, Spain

Status: Completed

Conditions: Cardiovascular Function; Gene Expression

Treatments: Dietary Supplement: Polyphenol-rich cocoa extract; Dietary Supplement: Chocolate cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01681394

PBMCS-CTNS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Product 1

Active Comparator group

Description:

250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)

Treatment:

Dietary Supplement: Polyphenol-rich cocoa extract

Control product

Placebo Comparator group

Description:

250 g of chocolate cream

Treatment:

Dietary Supplement: Chocolate cream