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Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics) (ProVegOmics)

Primary Purpose

Metabolic Syndrome, Hypertriglyceridemia, Fasting Blood Sugar Above Normal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diets with either predominantly animal protein sources.
Diets with predominantly plant protein sources
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Metabolomics, Plant Proteins, Dietary, Meat Proteins, Dietary Proteins, Metabolic Syndrome, Hypertriglyceridemia, Waist Circumference

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 25 and 35 kh/m² (terminals included)
  • Waist circumference ≥ 94 cm for men and ≥80 cm for women
  • at the choice, one of the following criteria: Triglyceridemia > 1.49g/L, fasting blood glucose≥ 5.6 mmol/L , a HDL cholesterol <1.03mmol/L for men or <1.29 mmol/L for women , systolic blood pressure≥ 130 mmHg or diastolic≥ 85 mmHg .

Exclusion Criteria:

  • Systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
  • pathology and medical treatment
  • diabetes
  • Smoking > 4 cigarettes /day
  • Alcohol consumption > 2 glasses/day
  • Antibiotics taken during the last 3 months before the clinical trial
  • Specific diets

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source

Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source

Arm Description

20 men or postmenopausal women between 25 and 55 years old with a high waist circumference and at the choice, one of the following criteria high triglyceridemia, blood sugar above standards,a lower than standard HDL-cholesterol level,slightly elevated blood pressure receiving diets with predominantly animal protein sources

20 men or postmenopausal women between 25 and 55 years old with a high waist circumference and at the choice, one of the following criteria high triglyceridemia, blood sugar above standards,a lower than standard HDL-cholesterol level,slightly elevated blood pressure receiving diets with predominantly plant protein sources

Outcomes

Primary Outcome Measures

changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

Secondary Outcome Measures

Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Food statement at inclusion
using 3 days food log before day 0

Full Information

First Posted
January 6, 2020
Last Updated
September 26, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes, UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).
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1. Study Identification

Unique Protocol Identification Number
NCT04236518
Brief Title
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)
Acronym
ProVegOmics
Official Title
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes, UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The dietary shift from animal to plant protein sources is one of the key aspects of the nutritional transition towards more sustainable food system and diets. However the metabolic implication of this shift in protein sources are still poorly understood. This project aims to characterize and understand the metabolic orientations specifically induced by animal and vegetable dietary proteins, in order to better analyze the metabolic reorientations that would result from the expected increase in the share of plant proteins in different dietary contexts, especially those of the Western type, often associated with the development of metabolic deregulations (obesity and cardiometabolic risk).
Detailed Description
The main objectives of this project are: Characterize the metabolic adaptations induced by animal or plant protein diets and their repercussions in terms of physiology and health. Characterize the medium-term metabolomic signatures induced by this shift in dietary protein sources Validate, in a human population, biomarkers of dietary animal or plant proteins, previously identified in pre-clinical studies. This clinical trial is open, monocentric, controlled, randomized, with a cross experimental design. 20 men or postmenopausal women will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from animal or vegetal sources. After a 2-week washout period(+21D/-7D), they will follow another 4 week of controlled diet with predominantly animal or plant protein depending on 1st intervention period diet. At the end of each intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling. The order in which participants will received the two diets will be randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypertriglyceridemia, Fasting Blood Sugar Above Normal, Lower Than Standard HDL-cholesterol Level, Slightly Elevated Blood Pressure
Keywords
Metabolomics, Plant Proteins, Dietary, Meat Proteins, Dietary Proteins, Metabolic Syndrome, Hypertriglyceridemia, Waist Circumference

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source
Arm Type
Experimental
Arm Description
20 men or postmenopausal women between 25 and 55 years old with a high waist circumference and at the choice, one of the following criteria high triglyceridemia, blood sugar above standards,a lower than standard HDL-cholesterol level,slightly elevated blood pressure receiving diets with predominantly animal protein sources
Arm Title
Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source
Arm Type
Experimental
Arm Description
20 men or postmenopausal women between 25 and 55 years old with a high waist circumference and at the choice, one of the following criteria high triglyceridemia, blood sugar above standards,a lower than standard HDL-cholesterol level,slightly elevated blood pressure receiving diets with predominantly plant protein sources
Intervention Type
Behavioral
Intervention Name(s)
Diets with either predominantly animal protein sources.
Intervention Description
20 men or postmenopausal women will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from animal sources. At the end of the intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling.
Intervention Type
Behavioral
Intervention Name(s)
Diets with predominantly plant protein sources
Intervention Description
20 men or postmenopausal women will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from vegetal sources. At the end of the intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling.
Primary Outcome Measure Information:
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 0
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 14
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 28
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 29
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 42
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 56
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 70
Title
changes of blood metabolomics
Description
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 71
Secondary Outcome Measure Information:
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 0
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 14
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 28
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 29
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 42
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 56
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 70
Title
Changes of urine metabolomics
Description
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Time Frame
day 71
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 0
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 14
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 28
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 29
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 42
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 56
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 70
Title
Changes in blood glucose
Description
The glucose concentrations will be determined by the blood samples taken by ELISA
Time Frame
day 71
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 0
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 14
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 28
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 29
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 42
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 56
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 70
Title
Changes in blood insulin
Description
The insulin concentrations will be determined in the blood samples and measured by ELISA
Time Frame
day 71
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 0
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 14
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 28
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 29
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 42
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 56
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 70
Title
Changes in blood cholesterol
Description
The cholesterol concentrations will be determined in the blood samples taken
Time Frame
day 71
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 0
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 14
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 28
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 29
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 42
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 56
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 70
Title
Changes in blood triglycerides
Description
The triglycerides concentrations will be determined in the blood samples taken
Time Frame
day 71
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 0
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 14
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 28
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 29
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 42
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 56
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 70
Title
changes in blood IL-6
Description
The IL-6 concentrations will be determined in the blood samples taken
Time Frame
day 71
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 0
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 14
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 28
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 29
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 42
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 56
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 70
Title
changes in blood IL-10
Description
The IL-10 concentrations will be determined in the blood samples taken
Time Frame
day 71
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 0
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 14
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 28
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 29
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 42
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 56
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 70
Title
changes in blood CRP
Description
The CRP concentrations will be determined in the blood samples taken
Time Frame
Day 71
Title
measure of protein synthesis by isotopic labelling
Description
measurement of protein synthesis using deuterium labelling water
Time Frame
Day 28
Title
measure of protein synthesis by isotopic labelling
Description
measurement of protein synthesis using deuterium labelling water
Time Frame
Day 29
Title
measure of protein synthesis by isotopic labelling
Description
measurement of protein synthesis using deuterium labelling water
Time Frame
Day 70
Title
measure of protein synthesis by isotopic labelling
Description
measurement of protein synthesis using deuterium labelling water
Time Frame
Day 71
Title
Measure of lipogenesis de novo by isotopic labelling
Description
measurement of lipogenesis using deuterium labelling water
Time Frame
Day 28
Title
Measure of lipogenesis de novo by isotopic labelling
Description
measurement of lipogenesis using deuterium labelling water
Time Frame
Day 29
Title
Measure of lipogenesis de novo by isotopic labelling
Description
measurement of lipogenesis using deuterium labelling water
Time Frame
Day 70
Title
Measure of lipogenesis de novo by isotopic labelling
Description
measurement of lipogenesis using deuterium labelling water
Time Frame
Day 71
Title
Changes in vascular function
Description
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Time Frame
Day 0
Title
Changes in vascular function
Description
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Time Frame
Day 28
Title
Changes in vascular function
Description
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Time Frame
Day 42
Title
Changes in vascular function
Description
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Time Frame
Day 70
Title
Changes in microcirculation
Description
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Time Frame
Day 0
Title
Changes in microcirculation
Description
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Time Frame
Day 28
Title
Changes in microcirculation
Description
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Time Frame
Day 42
Title
Changes in microcirculation
Description
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Time Frame
Day 70
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 0
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 14
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 28
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 29
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 42
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 56
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 70
Title
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Description
will be measured by qPCR
Time Frame
Day 71
Title
Changes in body composition
Description
will be determined using bioelectric impendence analysis, Quad Scan.
Time Frame
Day 0
Title
Changes in body composition
Description
will be determined using bioelectric impendence analysis, Quad Scan.
Time Frame
Day 28
Title
Changes in body composition
Description
will be determined using bioelectric impendence analysis, Quad Scan.
Time Frame
Day 42
Title
Changes in body composition
Description
will be determined using bioelectric impendence analysis, Quad Scan.
Time Frame
Day 70
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 0
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 14
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 28
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 29
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 42
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 56
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 70
Title
Changes of the microbiota (stool samples)
Description
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Time Frame
day 71
Title
Food statement at inclusion
Description
using 3 days food log before day 0
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 25 and 35 kh/m² (terminals included) Waist circumference ≥ 94 cm for men and ≥80 cm for women at the choice, one of the following criteria: Triglyceridemia > 1.49g/L, fasting blood glucose≥ 5.6 mmol/L , a HDL cholesterol <1.03mmol/L for men or <1.29 mmol/L for women , systolic blood pressure≥ 130 mmHg or diastolic≥ 85 mmHg . Exclusion Criteria: Systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg pathology and medical treatment diabetes Smoking > 4 cigarettes /day Alcohol consumption > 2 glasses/day Antibiotics taken during the last 3 months before the clinical trial Specific diets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle Pickering
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
63000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)

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