Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)
ProVegOmics
2 other identifiers
interventional
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2022
CompletedSeptember 27, 2022
September 1, 2022
1.9 years
January 6, 2020
September 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 0
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 14
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 28
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 29
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 42
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 56
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 70
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
day 71
Secondary Outcomes (101)
Changes of urine metabolomics
day 0
Changes of urine metabolomics
day 14
Changes of urine metabolomics
day 28
Changes of urine metabolomics
day 29
Changes of urine metabolomics
day 42
- +96 more secondary outcomes
Study Arms (2)
Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source
EXPERIMENTAL20 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
EXPERIMENTAL20 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Related Publications (1)
Lepine G, Mariotti F, Tremblay-Franco M, Courrent M, Verny MA, David J, Mathe V, Jame P, Anchisi A, Lefranc-Millot C, Perreau C, Guerin-Deremaux L, Chollet C, Castelli F, Chu-Van E, Huneau JF, Remond D, Pickering G, Fouillet H, Polakof S. Increasing plant protein in the diet induces changes in the plasma metabolome that may be beneficial for metabolic health. A randomized crossover study in males. Clin Nutr. 2024 Dec;43(12):146-157. doi: 10.1016/j.clnu.2024.10.009. Epub 2024 Oct 12.
PMID: 39454458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gisèle Pickering
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 22, 2020
Study Start
August 27, 2020
Primary Completion
August 5, 2022
Study Completion
August 5, 2022
Last Updated
September 27, 2022
Record last verified: 2022-09