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

Gene Expression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681394
• Other study ID #: PBMCS-CTNS-01
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: July 2, 2013
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Function
• Gene Expression

Intervention

Dietary Supplement:
• 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)
• Chocolate cream

Locations

Country	Name	City	State
Spain	Technological Center of Nutrition and Health (CTNS)	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression changes in PBMCs (using a microarray)		0-6 hours	No
Secondary	Blood pressure		0-2-3-6 hours	No
Secondary	Endothelial function (assessed by ischemic reactive hyperemia)		0-2-3-6 hours	No
Secondary	Plasma levels of procyanidins metabolites		0-6 hours	No