Development of Endothelial Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-09-19

Brief Summary

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The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

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Detailed Description

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The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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lipids

The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Group Type EXPERIMENTAL

Induction of endothelial function variations

Intervention Type BEHAVIORAL

flavonoids

The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Group Type OTHER

Induction of endothelial function variations

Intervention Type BEHAVIORAL

Interventions

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Induction of endothelial function variations

Intervention Type BEHAVIORAL

Other Intervention Names

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Improvement with cocoa polyphenol dose Induction of dysfunction with lipid dose

Eligibility Criteria

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Inclusion Criteria

* \- 40 to 65 years old
* male
* non-smokers

* Healthy subjects should not take antihypertensive or statin.
* Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.

\- subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.

Exclusion Criteria

* treatment vasodilator nitric oxide liberating,
* diabetes and coronary artery disease,
* chronic alcoholism,
* severe hepatic impairment,
* end stage renal failure or dialysis,
* neurological tremor,
* cancer, mental illness or other severe disease which can impact informed consent and / or results,
* Refusal to be registered in the National File of Volunteers
* Person in exclusion of the National Volunteer File

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes