Cardiovascular Function, Gene Expression
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTPolyphenol-rich cocoa extract
250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
DIETARY_SUPPLEMENTChocolate cream
Sponsors
Technological Centre of Nutrition and Health, Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1.Healthy males between the ages of 20 and 39 who do not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene expression changes in PBMCs (using a microarray) | 0-6 hours |
Secondary
| 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 |
Countries
Spain
Outcome results
None listed