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

September 26, 2022 updated by: University Hospital, Clermont-Ferrand

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

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

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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