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NCT Number: NCT01681394

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

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.

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Key information

Conditions

Cardiovascular Function Gene Expression

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Technological Center of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyphenol-rich cocoa extract

Dietary Supplement

250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)

Chocolate cream

Dietary Supplement

Primary outcomes

  1. Gene expression changes in PBMCs (using a microarray)

    Time frame: 0-6 hours

Secondary outcomes

  1. Blood pressure

    Time frame: 0-2-3-6 hours

  2. Endothelial function (assessed by ischemic reactive hyperemia)

    Time frame: 0-2-3-6 hours

  3. Plasma levels of procyanidins metabolites

    Time frame: 0-6 hours

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 7, 2012
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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