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Completed

NCT Number: NCT02006810

Development of Endothelial Biomarkers

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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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Induction of endothelial function variations

Behavioral

Other names: Improvement with cocoa polyphenol dose, Induction of dysfunction with lipid dose

Primary outcomes

  1. Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)

    Time frame: at 150 mn after the product intake

    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)

Secondary outcomes

  1. Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)

    Time frame: at 150 mn after the product intake

    Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by:

    • Cell Adhesion Molecule (CAM)
    • Micro-RNA (miRNA)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: NUTREND

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 10, 2013
Registry last updated
Sep 5, 2018

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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