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

• Sponsor: Technological Centre of Nutrition and Health, Spain (Other)
• Overall Status: Completed
• CT.gov ID: NCT01681394
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Function; Gene Expression	Dietary Supplement: Polyphenol-rich cocoa extract; Dietary Supplement: Chocolate cream	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gene expression changes in PBMCs (using a microarray) [0-6 hours]

Secondary Outcome Measures

1. Blood pressure [0-2-3-6 hours]

2. Endothelial function (assessed by ischemic reactive hyperemia) [0-2-3-6 hours]

3. Plasma levels of procyanidins metabolites [0-6 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Technological Center of Nutrition and Health (CTNS)	Reus	Tarragona	Spain	43204

Sponsors and Collaborators

• Technological Centre of Nutrition and Health, Spain

Investigators

• Principal Investigator: Rosa Solà, PhD, University Rovira i Virgili

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technological Centre of Nutrition and Health, Spain
• ClinicalTrials.gov Identifier: NCT01681394
• Other Study ID Numbers: PBMCS-CTNS-01
• First Posted: Sep 7, 2012
• Last Update Posted: Jul 3, 2013
• Last Verified: Jul 1, 2013

Study Results

No Results Posted as of Jul 3, 2013