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

NCT ID: NCT01681394

Last Updated: 2013-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

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.

Conditions

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Cardiovascular Function Gene Expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Product 1

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

Group Type ACTIVE_COMPARATOR

Polyphenol-rich cocoa extract

Intervention Type DIETARY_SUPPLEMENT

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

Control product

250 g of chocolate cream

Group Type PLACEBO_COMPARATOR

Chocolate cream

Intervention Type DIETARY_SUPPLEMENT

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Chocolate cream

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technological Centre of Nutrition and Health, Spain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa SolĂ , PhD

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

Locations

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Technological Center of Nutrition and Health (CTNS)

Reus, Tarragona, Spain

Site Status

Countries

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Spain

Other Identifiers

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PBMCS-CTNS-01

Identifier Type: -

Identifier Source: org_study_id

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