Clinical trial NCT04236518: Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes
name: UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).
First posted: 2020-01-22
Enrollment: 53
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: changes of blood metabolomics
timeFrame: day 0
measure: changes of blood metabolomics
timeFrame: day 14
measure: changes of blood metabolomics
timeFrame: day 28
measure: changes of blood metabolomics
timeFrame: day 29
measure: changes of blood metabolomics
timeFrame: day 42
measure: changes of blood metabolomics
timeFrame: day 56
measure: changes of blood metabolomics
timeFrame: day 70
measure: changes of blood metabolomics
timeFrame: day 71
Secondary outcomes:
measure: Changes of urine metabolomics
timeFrame: day 0
measure: Changes of urine metabolomics
timeFrame: day 14
measure: Changes of urine metabolomics
timeFrame: day 28
measure: Changes of urine metabolomics
timeFrame: day 29
measure: Changes of urine metabolomics
timeFrame: day 42
measure: Changes of urine metabolomics
timeFrame: day 56
measure: Changes of urine metabolomics
timeFrame: day 70
measure: Changes of urine metabolomics
timeFrame: day 71
measure: Changes in blood glucose
timeFrame: day 0
measure: Changes in blood glucose
timeFrame: day 14
measure: Changes in blood glucose
timeFrame: day 28
measure: Changes in blood glucose
timeFrame: day 29
measure: Changes in blood glucose
timeFrame: day 42
measure: Changes in blood glucose
timeFrame: day 56
measure: Changes in blood glucose
timeFrame: day 70
measure: Changes in blood glucose
timeFrame: day 71
measure: Changes in blood insulin
timeFrame: day 0
measure: Changes in blood insulin
timeFrame: day 14
measure: Changes in blood insulin
timeFrame: day 28
measure: Changes in blood insulin
timeFrame: day 29
measure: Changes in blood insulin
timeFrame: day 42
measure: Changes in blood insulin
timeFrame: day 56
measure: Changes in blood insulin
timeFrame: day 70
measure: Changes in blood insulin
timeFrame: day 71
measure: Changes in blood cholesterol
timeFrame: day 0
measure: Changes in blood cholesterol
timeFrame: day 14
measure: Changes in blood cholesterol
timeFrame: day 28
measure: Changes in blood cholesterol
timeFrame: day 29
measure: Changes in blood cholesterol
timeFrame: day 42
measure: Changes in blood cholesterol
timeFrame: day 56
measure: Changes in blood cholesterol
timeFrame: day 70
measure: Changes in blood cholesterol
timeFrame: day 71
measure: Changes in blood triglycerides
timeFrame: day 0
measure: Changes in blood triglycerides
timeFrame: day 14
measure: Changes in blood triglycerides
timeFrame: day 28
measure: Changes in blood triglycerides
timeFrame: day 29
measure: Changes in blood triglycerides
timeFrame: day 42
measure: Changes in blood triglycerides
timeFrame: day 56
measure: Changes in blood triglycerides
timeFrame: day 70
measure: Changes in blood triglycerides
timeFrame: day 71
measure: changes in blood IL-6
timeFrame: day 0
measure: changes in blood IL-6
timeFrame: day 14
measure: changes in blood IL-6
timeFrame: day 28
measure: changes in blood IL-6
timeFrame: day 29
measure: changes in blood IL-6
timeFrame: day 42
measure: changes in blood IL-6
timeFrame: day 56
measure: changes in blood IL-6
timeFrame: day 70
measure: changes in blood IL-6
timeFrame: day 71
measure: changes in blood IL-10
timeFrame: day 0
measure: changes in blood IL-10
timeFrame: day 14
measure: changes in blood IL-10
timeFrame: day 28
measure: changes in blood IL-10
timeFrame: day 29
measure: changes in blood IL-10
timeFrame: day 42
measure: changes in blood IL-10
timeFrame: day 56
measure: changes in blood IL-10
timeFrame: day 70
measure: changes in blood IL-10
timeFrame: day 71
measure: changes in blood CRP
timeFrame: Day 0
measure: changes in blood CRP
timeFrame: Day 14
measure: changes in blood CRP
timeFrame: Day 28
measure: changes in blood CRP
timeFrame: Day 29
measure: changes in blood CRP
timeFrame: Day 42
measure: changes in blood CRP
timeFrame: Day 56
measure: changes in blood CRP
timeFrame: Day 70
measure: changes in blood CRP
timeFrame: Day 71
measure: measure of protein synthesis by isotopic labelling
timeFrame: Day 28
measure: measure of protein synthesis by isotopic labelling
timeFrame: Day 29
measure: measure of protein synthesis by isotopic labelling
timeFrame: Day 70
measure: measure of protein synthesis by isotopic labelling
timeFrame: Day 71
measure: Measure of lipogenesis de novo by isotopic labelling
timeFrame: Day 28
measure: Measure of lipogenesis de novo by isotopic labelling
timeFrame: Day 29
measure: Measure of lipogenesis de novo by isotopic labelling
timeFrame: Day 70
measure: Measure of lipogenesis de novo by isotopic labelling
timeFrame: Day 71
measure: Changes in vascular function
timeFrame: Day 0
measure: Changes in vascular function
timeFrame: Day 28
measure: Changes in vascular function
timeFrame: Day 42
measure: Changes in vascular function
timeFrame: Day 70
measure: Changes in microcirculation
timeFrame: Day 0
measure: Changes in microcirculation
timeFrame: Day 28
measure: Changes in microcirculation
timeFrame: Day 42
measure: Changes in microcirculation
timeFrame: Day 70
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 0
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 14
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 28
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 29
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 42
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 56
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 70
measure: Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
timeFrame: Day 71
measure: Changes in body composition
timeFrame: Day 0
measure: Changes in body composition
timeFrame: Day 28
measure: Changes in body composition
timeFrame: Day 42
measure: Changes in body composition
timeFrame: Day 70
measure: Changes of the microbiota (stool samples)
timeFrame: day 0
measure: Changes of the microbiota (stool samples)
timeFrame: day 14
measure: Changes of the microbiota (stool samples)
timeFrame: day 28
measure: Changes of the microbiota (stool samples)
timeFrame: day 29
measure: Changes of the microbiota (stool samples)
timeFrame: day 42
measure: Changes of the microbiota (stool samples)
timeFrame: day 56
measure: Changes of the microbiota (stool samples)
timeFrame: day 70
measure: Changes of the microbiota (stool samples)
timeFrame: day 71
measure: Food statement at inclusion
timeFrame: day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering
role: PRINCIPAL_INVESTIGATOR
References: