- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236518
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics) (ProVegOmics)
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
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).
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- CHU de Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source
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 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.
|
Experimental: Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of blood metabolomics
Time Frame: day 0
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 0
|
changes of blood metabolomics
Time Frame: day 14
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 14
|
changes of blood metabolomics
Time Frame: day 28
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 28
|
changes of blood metabolomics
Time Frame: day 29
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 29
|
changes of blood metabolomics
Time Frame: day 42
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 42
|
changes of blood metabolomics
Time Frame: day 56
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 56
|
changes of blood metabolomics
Time Frame: day 70
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 70
|
changes of blood metabolomics
Time Frame: day 71
|
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 71
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of urine metabolomics
Time Frame: day 0
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 0
|
Changes of urine metabolomics
Time Frame: day 14
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 14
|
Changes of urine metabolomics
Time Frame: day 28
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 28
|
Changes of urine metabolomics
Time Frame: day 29
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 29
|
Changes of urine metabolomics
Time Frame: day 42
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 42
|
Changes of urine metabolomics
Time Frame: day 56
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 56
|
Changes of urine metabolomics
Time Frame: day 70
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 70
|
Changes of urine metabolomics
Time Frame: day 71
|
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
|
day 71
|
Changes in blood glucose
Time Frame: day 0
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 0
|
Changes in blood glucose
Time Frame: day 14
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 14
|
Changes in blood glucose
Time Frame: day 28
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 28
|
Changes in blood glucose
Time Frame: day 29
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 29
|
Changes in blood glucose
Time Frame: day 42
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 42
|
Changes in blood glucose
Time Frame: day 56
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 56
|
Changes in blood glucose
Time Frame: day 70
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 70
|
Changes in blood glucose
Time Frame: day 71
|
The glucose concentrations will be determined by the blood samples taken by ELISA
|
day 71
|
Changes in blood insulin
Time Frame: day 0
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 0
|
Changes in blood insulin
Time Frame: day 14
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 14
|
Changes in blood insulin
Time Frame: day 28
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 28
|
Changes in blood insulin
Time Frame: day 29
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 29
|
Changes in blood insulin
Time Frame: day 42
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 42
|
Changes in blood insulin
Time Frame: day 56
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 56
|
Changes in blood insulin
Time Frame: day 70
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 70
|
Changes in blood insulin
Time Frame: day 71
|
The insulin concentrations will be determined in the blood samples and measured by ELISA
|
day 71
|
Changes in blood cholesterol
Time Frame: day 0
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 0
|
Changes in blood cholesterol
Time Frame: day 14
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 14
|
Changes in blood cholesterol
Time Frame: day 28
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 28
|
Changes in blood cholesterol
Time Frame: day 29
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 29
|
Changes in blood cholesterol
Time Frame: day 42
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 42
|
Changes in blood cholesterol
Time Frame: day 56
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 56
|
Changes in blood cholesterol
Time Frame: day 70
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 70
|
Changes in blood cholesterol
Time Frame: day 71
|
The cholesterol concentrations will be determined in the blood samples taken
|
day 71
|
Changes in blood triglycerides
Time Frame: day 0
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 0
|
Changes in blood triglycerides
Time Frame: day 14
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 14
|
Changes in blood triglycerides
Time Frame: day 28
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 28
|
Changes in blood triglycerides
Time Frame: day 29
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 29
|
Changes in blood triglycerides
Time Frame: day 42
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 42
|
Changes in blood triglycerides
Time Frame: day 56
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 56
|
Changes in blood triglycerides
Time Frame: day 70
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 70
|
Changes in blood triglycerides
Time Frame: day 71
|
The triglycerides concentrations will be determined in the blood samples taken
|
day 71
|
changes in blood IL-6
Time Frame: day 0
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 0
|
changes in blood IL-6
Time Frame: day 14
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 14
|
changes in blood IL-6
Time Frame: day 28
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 28
|
changes in blood IL-6
Time Frame: day 29
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 29
|
changes in blood IL-6
Time Frame: day 42
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 42
|
changes in blood IL-6
Time Frame: day 56
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 56
|
changes in blood IL-6
Time Frame: day 70
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 70
|
changes in blood IL-6
Time Frame: day 71
|
The IL-6 concentrations will be determined in the blood samples taken
|
day 71
|
changes in blood IL-10
Time Frame: day 0
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 0
|
changes in blood IL-10
Time Frame: day 14
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 14
|
changes in blood IL-10
Time Frame: day 28
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 28
|
changes in blood IL-10
Time Frame: day 29
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 29
|
changes in blood IL-10
Time Frame: day 42
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 42
|
changes in blood IL-10
Time Frame: day 56
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 56
|
changes in blood IL-10
Time Frame: day 70
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 70
|
changes in blood IL-10
Time Frame: day 71
|
The IL-10 concentrations will be determined in the blood samples taken
|
day 71
|
changes in blood CRP
Time Frame: Day 0
|
The CRP concentrations will be determined in the blood samples taken
|
Day 0
|
changes in blood CRP
Time Frame: Day 14
|
The CRP concentrations will be determined in the blood samples taken
|
Day 14
|
changes in blood CRP
Time Frame: Day 28
|
The CRP concentrations will be determined in the blood samples taken
|
Day 28
|
changes in blood CRP
Time Frame: Day 29
|
The CRP concentrations will be determined in the blood samples taken
|
Day 29
|
changes in blood CRP
Time Frame: Day 42
|
The CRP concentrations will be determined in the blood samples taken
|
Day 42
|
changes in blood CRP
Time Frame: Day 56
|
The CRP concentrations will be determined in the blood samples taken
|
Day 56
|
changes in blood CRP
Time Frame: Day 70
|
The CRP concentrations will be determined in the blood samples taken
|
Day 70
|
changes in blood CRP
Time Frame: Day 71
|
The CRP concentrations will be determined in the blood samples taken
|
Day 71
|
measure of protein synthesis by isotopic labelling
Time Frame: Day 28
|
measurement of protein synthesis using deuterium labelling water
|
Day 28
|
measure of protein synthesis by isotopic labelling
Time Frame: Day 29
|
measurement of protein synthesis using deuterium labelling water
|
Day 29
|
measure of protein synthesis by isotopic labelling
Time Frame: Day 70
|
measurement of protein synthesis using deuterium labelling water
|
Day 70
|
measure of protein synthesis by isotopic labelling
Time Frame: Day 71
|
measurement of protein synthesis using deuterium labelling water
|
Day 71
|
Measure of lipogenesis de novo by isotopic labelling
Time Frame: Day 28
|
measurement of lipogenesis using deuterium labelling water
|
Day 28
|
Measure of lipogenesis de novo by isotopic labelling
Time Frame: Day 29
|
measurement of lipogenesis using deuterium labelling water
|
Day 29
|
Measure of lipogenesis de novo by isotopic labelling
Time Frame: Day 70
|
measurement of lipogenesis using deuterium labelling water
|
Day 70
|
Measure of lipogenesis de novo by isotopic labelling
Time Frame: Day 71
|
measurement of lipogenesis using deuterium labelling water
|
Day 71
|
Changes in vascular function
Time Frame: Day 0
|
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
|
Day 0
|
Changes in vascular function
Time Frame: Day 28
|
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
|
Day 28
|
Changes in vascular function
Time Frame: Day 42
|
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
|
Day 42
|
Changes in vascular function
Time Frame: Day 70
|
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
|
Day 70
|
Changes in microcirculation
Time Frame: Day 0
|
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
|
Day 0
|
Changes in microcirculation
Time Frame: Day 28
|
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
|
Day 28
|
Changes in microcirculation
Time Frame: Day 42
|
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
|
Day 42
|
Changes in microcirculation
Time Frame: Day 70
|
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
|
Day 70
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 0
|
will be measured by qPCR
|
Day 0
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 14
|
will be measured by qPCR
|
Day 14
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 28
|
will be measured by qPCR
|
Day 28
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 29
|
will be measured by qPCR
|
Day 29
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 42
|
will be measured by qPCR
|
Day 42
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 56
|
will be measured by qPCR
|
Day 56
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 70
|
will be measured by qPCR
|
Day 70
|
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
Time Frame: Day 71
|
will be measured by qPCR
|
Day 71
|
Changes in body composition
Time Frame: Day 0
|
will be determined using bioelectric impendence analysis, Quad Scan.
|
Day 0
|
Changes in body composition
Time Frame: Day 28
|
will be determined using bioelectric impendence analysis, Quad Scan.
|
Day 28
|
Changes in body composition
Time Frame: Day 42
|
will be determined using bioelectric impendence analysis, Quad Scan.
|
Day 42
|
Changes in body composition
Time Frame: Day 70
|
will be determined using bioelectric impendence analysis, Quad Scan.
|
Day 70
|
Changes of the microbiota (stool samples)
Time Frame: day 0
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 0
|
Changes of the microbiota (stool samples)
Time Frame: day 14
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 14
|
Changes of the microbiota (stool samples)
Time Frame: day 28
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 28
|
Changes of the microbiota (stool samples)
Time Frame: day 29
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 29
|
Changes of the microbiota (stool samples)
Time Frame: day 42
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 42
|
Changes of the microbiota (stool samples)
Time Frame: day 56
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 56
|
Changes of the microbiota (stool samples)
Time Frame: day 70
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 70
|
Changes of the microbiota (stool samples)
Time Frame: day 71
|
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
|
day 71
|
Food statement at inclusion
Time Frame: day 0
|
using 3 days food log before day 0
|
day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2019 PICKERING 2
- 2019-A02447-50 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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