Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)
- Conditions
- HypertriglyceridemiaFasting Blood Sugar Above NormalLower Than Standard HDL-cholesterol LevelSlightly Elevated Blood PressureMetabolic Syndrome
- Interventions
- Behavioral: Diets with either predominantly animal protein sources.Behavioral: Diets with predominantly plant protein sources
- Registration Number
- NCT04236518
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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 .
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source Diets with either 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 animal protein sources Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source Diets with predominantly plant 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
- Primary Outcome Measures
Name Time Method changes of blood metabolomics day 71 the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
- Secondary Outcome Measures
Name Time Method changes in blood IL-10 day 71 The IL-10 concentrations will be determined in the blood samples taken
Changes of urine metabolomics day 71 the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Changes in blood glucose day 71 The glucose concentrations will be determined by the blood samples taken by ELISA
Changes in blood insulin day 71 The insulin concentrations will be determined in the blood samples and measured by ELISA
Changes in blood cholesterol day 71 The cholesterol concentrations will be determined in the blood samples taken
Changes in blood triglycerides day 71 The triglycerides concentrations will be determined in the blood samples taken
changes in blood IL-6 day 71 The IL-6 concentrations will be determined in the blood samples taken
measure of protein synthesis by isotopic labelling Day 71 measurement of protein synthesis using deuterium labelling water
Measure of lipogenesis de novo by isotopic labelling Day 71 measurement of lipogenesis using deuterium labelling water
Changes in vascular function 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
changes in blood CRP Day 71 The CRP concentrations will be determined in the blood samples taken
Changes in microcirculation Day 70 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) Day 71 will be measured by qPCR
Changes in body composition Day 70 will be determined using bioelectric impendence analysis, Quad Scan.
Changes of the microbiota (stool samples) day 71 will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Food statement at inclusion day 0 using 3 days food log before day 0
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France