Development of Endothelial Biomarkers

Metabolic Syndrome Clinical Trial

— NUTREND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006810
• Other study ID #: CHU-0168
• Secondary ID: 2013-A00205-40
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 19, 2017

Study information

• Verified date: September 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 19, 2017
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Induction of endothelial function variations

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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