Metabolic SyndromeProVegOmicsNCT04236518
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)
A study testing Diets with either predominantly animal protein sources. and Diets with predominantly plant protein sources in people with Metabolic Syndrome and Hypertriglyceridemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Hypertriglyceridemia, Fasting Blood Sugar Above Normal
- What is being tested?
- Diets with either predominantly animal protein sources. and Diets with predominantly plant protein sources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2020to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
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).
Read the 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
- Being tested
- Diets with either predominantly animal protein sources., Diets with predominantly plant protein sources
- Keywords
- Metabolomics, Plant Proteins, Dietary, Meat Proteins, Dietary Proteins, Metabolic Syndrome, Hypertriglyceridemia, Waist Circumference
- Medical subject headings
- Metabolic Syndrome, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diets with either predominantly animal protein sources.Behavioural
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.
Diets with predominantly plant protein sourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source | Experimental | 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 Receives: Behavioral: Diets with either predominantly animal protein sources. |
| Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source | Experimental | 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 Receives: Behavioral: Diets with predominantly plant protein sources |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 0
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 14
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 28
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 29
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 42
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 56
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 70
changes of blood metabolomics
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 71
Secondary outcomes (101)
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 0
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 14
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 28
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 29
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 42
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 56
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 70
Changes of urine metabolomics
the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry
Measured: day 71
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 0
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 14
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 28
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 29
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 42
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 56
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 70
Changes in blood glucose
The glucose concentrations will be determined by the blood samples taken by ELISA
Measured: day 71
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 0
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 14
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 28
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 29
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 42
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 56
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 70
Changes in blood insulin
The insulin concentrations will be determined in the blood samples and measured by ELISA
Measured: day 71
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 0
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 14
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 28
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 29
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 42
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 56
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 70
Changes in blood cholesterol
The cholesterol concentrations will be determined in the blood samples taken
Measured: day 71
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 0
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 14
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 28
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 29
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 42
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 56
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 70
Changes in blood triglycerides
The triglycerides concentrations will be determined in the blood samples taken
Measured: day 71
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 0
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 14
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 28
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 29
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 42
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 56
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 70
changes in blood IL-6
The IL-6 concentrations will be determined in the blood samples taken
Measured: day 71
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 0
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 14
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 28
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 29
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 42
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 56
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 70
changes in blood IL-10
The IL-10 concentrations will be determined in the blood samples taken
Measured: day 71
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 0
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 14
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 28
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 29
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 42
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 56
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 70
changes in blood CRP
The CRP concentrations will be determined in the blood samples taken
Measured: Day 71
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
Measured: Day 28
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
Measured: Day 29
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
Measured: Day 70
measure of protein synthesis by isotopic labelling
measurement of protein synthesis using deuterium labelling water
Measured: Day 71
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measured: Day 28
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measured: Day 29
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measured: Day 70
Measure of lipogenesis de novo by isotopic labelling
measurement of lipogenesis using deuterium labelling water
Measured: Day 71
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Measured: Day 0
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Measured: Day 28
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Measured: Day 42
Changes in vascular function
will be determined by measuring minimal and maximal diameter of brachial artery in mm and the percentage of dilatation using the Flow-Mediated Dilatation GE echographer
Measured: Day 70
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Measured: Day 0
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Measured: Day 28
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Measured: Day 42
Changes in microcirculation
will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000
Measured: Day 70
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 0
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 14
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 28
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 29
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 42
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 56
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 70
Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)
will be measured by qPCR
Measured: Day 71
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Measured: Day 0
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Measured: Day 28
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Measured: Day 42
Changes in body composition
will be determined using bioelectric impendence analysis, Quad Scan.
Measured: Day 70
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 0
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 14
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 28
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 29
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 42
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 56
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 70
Changes of the microbiota (stool samples)
will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA
Measured: day 71
Food statement at inclusion
using 3 days food log before day 0
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start27 Aug 2020
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes, UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236518
- Sponsor's protocol ID
- RBHP 2019 PICKERING 2
- Other IDs
- 2019-A02447-50
- Acronym
- ProVegOmics
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39454458
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
- ClinicalTrials.gov ID
- NCT04236518
- Acronym / sponsor ID
- ProVegOmics / RBHP 2019 PICKERING 2
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes, UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source | Experimental | Behavioral: Diets with either predominantly animal protein sources.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 |
| Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source | Experimental | Behavioral: Diets with predominantly plant protein sources20 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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (7 listed)
- Systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
- pathology and medical treatment
- diabetes
- Smoking > 4 cigarettes /day
- Alcohol consumption > 2 glasses/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source |
| Diets with predominantly plant protein sources20 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. | Behavioural | Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source |
Primary outcome
changes of blood metabolomics
Time frame: day 0
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 14
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 28
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 29
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 42
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 56
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 70
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
changes of blood metabolomics
Time frame: day 71
the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry
101 secondary outcomes
Changes of urine metabolomics
Time frame: day 0
Changes of urine metabolomics
Time frame: day 14
Changes of urine metabolomics
Time frame: day 28
Changes of urine metabolomics
Time frame: day 29
Changes of urine metabolomics
Time frame: day 42
Changes of urine metabolomics
Time frame: day 56
Changes of urine metabolomics
Time frame: day 70
Changes of urine metabolomics
Time frame: day 71
Changes in blood glucose
Time frame: day 0
Changes in blood glucose
Time frame: day 14
Changes in blood glucose
Time frame: day 28
Changes in blood glucose
Time frame: day 29
Changes in blood glucose
Time frame: day 42
Changes in blood glucose
Time frame: day 56
Changes in blood glucose
Time frame: day 70
Changes in blood glucose
Time frame: day 71
Changes in blood insulin
Time frame: day 0
Changes in blood insulin
Time frame: day 14
Changes in blood insulin
Time frame: day 28
Changes in blood insulin
Time frame: day 29
Changes in blood insulin
Time frame: day 42
Changes in blood insulin
Time frame: day 56
Changes in blood insulin
Time frame: day 70
Changes in blood insulin
Time frame: day 71
Changes in blood cholesterol
Time frame: day 0
Changes in blood cholesterol
Time frame: day 14
Changes in blood cholesterol
Time frame: day 28
Changes in blood cholesterol
Time frame: day 29
Changes in blood cholesterol
Time frame: day 42
Changes in blood cholesterol
Time frame: day 56
Changes in blood cholesterol
Time frame: day 70
Changes in blood cholesterol
Time frame: day 71
Changes in blood triglycerides
Time frame: day 0
Changes in blood triglycerides
Time frame: day 14
Changes in blood triglycerides
Time frame: day 28
Changes in blood triglycerides
Time frame: day 29
Changes in blood triglycerides
Time frame: day 42
Changes in blood triglycerides
Time frame: day 56
Changes in blood triglycerides
Time frame: day 70
Changes in blood triglycerides
Time frame: day 71
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 39454458Lepine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diets with either predominantly animal protein sources. and Diets with predominantly plant protein sources in people with Metabolic Syndrome and Hypertriglyceridemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of blood metabolomics (time frame: day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.