Nutritional Transitions to More Plant Proteins & Less NCT04236518

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT04236518
Other study ID #	RBHP 2019 PICKERING 2
Secondary ID	2019-A02447-50
Status	Completed
Phase	N/A
First received
Last updated
Start date	August 27, 2020
Est. completion date	August 5, 2022

Study information
Verified date	September 2022
Source	University Hospital, Clermont-Ferrand
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status	Completed
Enrollment	53
Est. completion date	August 5, 2022
Est. primary completion date	August 5, 2022
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	25 Years to 55 Years
Eligibility	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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diets with either 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.
• 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.

Locations
Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors *(3)*
Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05)., UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes

Country where clinical trial is conducted

France,

Outcome
Type	Measure	Description	Time frame
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 0
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 14
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 28
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 29
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 42
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 56
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 70
Primary	changes of blood metabolomics	the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 71
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 0
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 14
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 28
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 29
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 42
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 56
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 70
Secondary	Changes of urine metabolomics	the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry	day 71
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 0
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 14
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 28
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 29
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 42
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 56
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 70
Secondary	Changes in blood glucose	The glucose concentrations will be determined by the blood samples taken by ELISA	day 71
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 0
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 14
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 28
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 29
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 42
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 56
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 70
Secondary	Changes in blood insulin	The insulin concentrations will be determined in the blood samples and measured by ELISA	day 71
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 0
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 14
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 28
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 29
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 42
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 56
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 70
Secondary	Changes in blood cholesterol	The cholesterol concentrations will be determined in the blood samples taken	day 71
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 0
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 14
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 28
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 29
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 42
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 56
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 70
Secondary	Changes in blood triglycerides	The triglycerides concentrations will be determined in the blood samples taken	day 71
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 0
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 14
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 28
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 29
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 42
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 56
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 70
Secondary	changes in blood IL-6	The IL-6 concentrations will be determined in the blood samples taken	day 71
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 0
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 14
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 28
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 29
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 42
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 56
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 70
Secondary	changes in blood IL-10	The IL-10 concentrations will be determined in the blood samples taken	day 71
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 0
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 14
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 28
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 29
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 42
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 56
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 70
Secondary	changes in blood CRP	The CRP concentrations will be determined in the blood samples taken	Day 71
Secondary	measure of protein synthesis by isotopic labelling	measurement of protein synthesis using deuterium labelling water	Day 28
Secondary	measure of protein synthesis by isotopic labelling	measurement of protein synthesis using deuterium labelling water	Day 29
Secondary	measure of protein synthesis by isotopic labelling	measurement of protein synthesis using deuterium labelling water	Day 70
Secondary	measure of protein synthesis by isotopic labelling	measurement of protein synthesis using deuterium labelling water	Day 71
Secondary	Measure of lipogenesis de novo by isotopic labelling	measurement of lipogenesis using deuterium labelling water	Day 28
Secondary	Measure of lipogenesis de novo by isotopic labelling	measurement of lipogenesis using deuterium labelling water	Day 29
Secondary	Measure of lipogenesis de novo by isotopic labelling	measurement of lipogenesis using deuterium labelling water	Day 70
Secondary	Measure of lipogenesis de novo by isotopic labelling	measurement of lipogenesis using deuterium labelling water	Day 71
Secondary	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	Day 0
Secondary	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	Day 28
Secondary	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	Day 42
Secondary	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	Day 70
Secondary	Changes in microcirculation	will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000	Day 0
Secondary	Changes in microcirculation	will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000	Day 28
Secondary	Changes in microcirculation	will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000	Day 42
Secondary	Changes in microcirculation	will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000	Day 70
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 0
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 14
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 28
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 29
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 42
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 56
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 70
Secondary	Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)	will be measured by qPCR	Day 71
Secondary	Changes in body composition	will be determined using bioelectric impendence analysis, Quad Scan.	Day 0
Secondary	Changes in body composition	will be determined using bioelectric impendence analysis, Quad Scan.	Day 28
Secondary	Changes in body composition	will be determined using bioelectric impendence analysis, Quad Scan.	Day 42
Secondary	Changes in body composition	will be determined using bioelectric impendence analysis, Quad Scan.	Day 70
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 0
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 14
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 28
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 29
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 42
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 56
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 70
Secondary	Changes of the microbiota (stool samples)	will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA	day 71
Secondary	Food statement at inclusion	using 3 days food log before day 0	day 0

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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)

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (3)

Country where clinical trial is conducted

Outcome