NCT04236518

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2020-08-27
• Primary completion: 2022-08-05
• Completion: 2022-08-05
• First posted: 2020-01-22
• Last updated: 2022-09-27

Locations

1 site across 1 country: France