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

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

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.

Study Overview

• Status: Completed
• Conditions: Gene Expression; Cardiovascular Function
• Intervention / Treatment: Dietary supplement: Polyphenol-rich cocoa extract; Dietary supplement: Chocolate cream

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Technological Center of Nutrition and Health (CTNS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Product 1; 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; 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
PLACEBO_COMPARATOR: Control product; 250 g of chocolate cream	Dietary supplement: Chocolate cream

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Technological Centre of Nutrition and Health, Spain
• Investigators: Principal Investigator: Rosa Solà, PhD, University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (ESTIMATE): September 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: PBMCS-CTNS-01