Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04236518
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2020-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProVegOmics
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).
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02447-50 | OTHER | ANSM | View |