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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Slightly Elevated Blood Pressure; Hypertriglyceridemia; Lower Than Standard HDL-cholesterol Level; Fasting Blood Sugar Above Normal; Metabolic Syndrome

Treatments: Behavioral: Diets with either predominantly animal protein sources.; Behavioral: Diets with predominantly plant protein sources

Study type: Interventional

Funder types: Other

Identifiers

NCT04236518

RBHP 2019 PICKERING 2

2019-A02447-50 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source

Experimental group

Description:

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

Treatment:

Behavioral: Diets with either predominantly animal protein sources.

Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source

Experimental group

Description:

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

Treatment:

Behavioral: Diets with predominantly plant protein sources