Development of Endothelial Biomarkers

Study Overview
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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.

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).

Official Title
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Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Induction of endothelial function variations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 40 to 65 years old male non-smokers Specific inclusion criteria for healthy subjects : 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. Specific inclusion criteria for subjects with metabolic syndrome : - 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lipids<br>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). | Behavioral: Induction of endothelial function variations<br> <br> * Other names: Induction of dysfunction with lipid dose;|
| Other: flavonoids<br>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). | Behavioral: Induction of endothelial function variations<br> <br> * Other names: Induction of dysfunction with lipid dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE) | Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: - Flow Mediated Dilatation (FMD) (reference) Compared to: Hyperemic Velocity Time Integral (VTI) Endothelial microparticles (MPE) | at 150 mn after the product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA) | Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: Cell Adhesion Molecule (CAM) Micro-RNA (miRNA) | at 150 mn after the product intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelium biomarkers, Atherosclerotic disease, Endothelial function, Nutritional stimuli