Completed

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

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What is being tested

Polyphenol-rich cocoa extract

+ Chocolate cream

Dietary Supplement
Who is being recruted

From 20 to 35 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorTechnological Centre of Nutrition and Health, Spain
Last updated: July 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01681394
Principal SponsorTechnological Centre of Nutrition and Health, Spain
Last updated: July 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
250 g of chocolate cream

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Technological Center of Nutrition and Health (CTNS)

Reus, SpainOpen Technological Center of Nutrition and Health (CTNS) in Google Maps
CompletedOne Study Center