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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier:
NCT01681394
First received: September 5, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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 Intervention
Cardiovascular Function
Gene Expression
Dietary Supplement: Polyphenol-rich cocoa extract
Dietary Supplement: Chocolate cream

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Technological Centre of Nutrition and Health, Spain:

Primary Outcome Measures:
  • Gene expression changes in PBMCs (using a microarray) [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 0-2-3-6 hours ] [ Designated as safety issue: No ]
  • Endothelial function (assessed by ischemic reactive hyperemia) [ Time Frame: 0-2-3-6 hours ] [ Designated as safety issue: No ]
  • Plasma levels of procyanidins metabolites [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681394

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT01681394     History of Changes
Other Study ID Numbers: PBMCS-CTNS-01
Study First Received: September 5, 2012
Last Updated: July 2, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on August 28, 2014