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Development of Endothelial Biomarkers (NUTREND)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Induction of endothelial function variations
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metabolic Syndrome focused on measuring Endothelium biomarkers, Atherosclerotic disease, Endothelial function, Nutritional stimuli

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

lipids

flavonoids

Arm 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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
September 24, 2013
Last Updated
September 4, 2018
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02006810
Brief Title
Development of Endothelial Biomarkers
Acronym
NUTREND
Official Title
Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Endothelium biomarkers, Atherosclerotic disease, Endothelial function, Nutritional stimuli

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lipids
Arm Type
Experimental
Arm 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).
Arm Title
flavonoids
Arm Type
Other
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Induction of endothelial function variations
Other Intervention Name(s)
Improvement with cocoa polyphenol dose, Induction of dysfunction with lipid dose
Primary Outcome Measure Information:
Title
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
Description
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)
Time Frame
at 150 mn after the product intake
Secondary Outcome Measure Information:
Title
Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)
Description
Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: Cell Adhesion Molecule (CAM) Micro-RNA (miRNA)
Time Frame
at 150 mn after the product intake

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BARBER CHAMOUX
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Development of Endothelial Biomarkers

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