Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Gene expression changes in PBMCs (using a microarray) [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2012 |
| Estimated 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 |
Inclusion Criteria:
1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.
Exclusion Criteria:
- Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
- Smokers
- Regular medication
- Consumption of medication during the last week
- Following a weight-loss diet
- Vegetarians
- Abnormal glucose levels
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Anemia
- Allergy
Contacts and Locations| Spain | |
| Technological Center of Nutrition and Health (CTNS) | |
| Reus, Tarragona, Spain, 43204 | |
| 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: | January 4, 2013 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
ClinicalTrials.gov processed this record on May 23, 2013