Development of Endothelial Biomarkers

NCT02006810 | Completed

• 2 other identifiers: CHU-01682013-A00205-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Endothelium biomarkers; Atherosclerotic disease; Endothelial function; Nutritional stimuli

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  at 150 mn after the product intake

Study Arms (2)

lipids

EXPERIMENTAL

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

flavonoids

OTHER

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

Interventions

Induction of endothelial function variations BEHAVIORAL

Also known as: Improvement with cocoa polyphenol dose, Induction of dysfunction with lipid dose

flavonoids; lipids

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicolas BARBER CHAMOUX

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: December 10, 2013
• Study Start: July 1, 2013
• Primary Completion: December 19, 2016
• Study Completion: September 19, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

FR (1)