Development of Endothelial Biomarkers (NUTREND)

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Behavioral: Induction of endothelial function variations

Study type

Interventional

Funder types

Other

Identifiers

NCT02006810

2013-A00205-40

CHU-0168

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 patients

Sex

Male

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

50 participants in 2 patient groups

lipids

Experimental group

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).

Treatment:

Behavioral: Induction of endothelial function variations

flavonoids

Other group

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).

Treatment:

Behavioral: Induction of endothelial function variations

Trial contacts and locations

1

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