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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of blood metabolomics', 'timeFrame': 'day 0', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 14', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 28', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 29', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 42', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 56', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 70', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'changes of blood metabolomics', 'timeFrame': 'day 71', 'description': 'the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}], 'secondaryOutcomes': [{'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 0', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 14', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 28', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 29', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 42', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 56', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 70', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes of urine metabolomics', 'timeFrame': 'day 71', 'description': 'the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 0', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 14', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 28', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 29', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 42', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 56', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 70', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood glucose', 'timeFrame': 'day 71', 'description': 'The glucose concentrations will be determined by the blood samples taken by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 0', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 14', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 28', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 29', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 42', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 56', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 70', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood insulin', 'timeFrame': 'day 71', 'description': 'The insulin concentrations will be determined in the blood samples and measured by ELISA'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 0', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 14', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 28', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 29', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 42', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 56', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 70', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood cholesterol', 'timeFrame': 'day 71', 'description': 'The cholesterol concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 0', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 14', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 28', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 29', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 42', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 56', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 70', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'Changes in blood triglycerides', 'timeFrame': 'day 71', 'description': 'The triglycerides concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 0', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 14', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 28', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 29', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 42', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 56', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 70', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-6', 'timeFrame': 'day 71', 'description': 'The IL-6 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 0', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 14', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 28', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 29', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 42', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 56', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 70', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood IL-10', 'timeFrame': 'day 71', 'description': 'The IL-10 concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 0', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 14', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 28', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 29', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 42', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 56', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 70', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'changes in blood CRP', 'timeFrame': 'Day 71', 'description': 'The CRP concentrations will be determined in the blood samples taken'}, {'measure': 'measure of protein synthesis by isotopic labelling', 'timeFrame': 'Day 28', 'description': 'measurement of protein synthesis using deuterium labelling water'}, {'measure': 'measure of protein synthesis by isotopic labelling', 'timeFrame': 'Day 29', 'description': 'measurement of protein synthesis using deuterium labelling water'}, {'measure': 'measure of protein synthesis by isotopic labelling', 'timeFrame': 'Day 70', 'description': 'measurement of protein synthesis using deuterium labelling water'}, {'measure': 'measure of protein synthesis by isotopic labelling', 'timeFrame': 'Day 71', 'description': 'measurement of protein synthesis using deuterium labelling water'}, {'measure': 'Measure of lipogenesis de novo by isotopic labelling', 'timeFrame': 'Day 28', 'description': 'measurement of lipogenesis using deuterium labelling water'}, {'measure': 'Measure of lipogenesis de novo by isotopic labelling', 'timeFrame': 'Day 29', 'description': 'measurement of lipogenesis using deuterium labelling water'}, {'measure': 'Measure of lipogenesis de novo by isotopic labelling', 'timeFrame': 'Day 70', 'description': 'measurement of lipogenesis using deuterium labelling water'}, {'measure': 'Measure of lipogenesis de novo by isotopic labelling', 'timeFrame': 'Day 71', 'description': 'measurement of lipogenesis using deuterium labelling water'}, {'measure': 'Changes in vascular function', 'timeFrame': 'Day 0', 'description': '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'}, {'measure': 'Changes in vascular function', 'timeFrame': 'Day 28', 'description': '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'}, {'measure': 'Changes in vascular function', 'timeFrame': 'Day 42', 'description': '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'}, {'measure': 'Changes in vascular function', 'timeFrame': 'Day 70', 'description': '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'}, {'measure': 'Changes in microcirculation', 'timeFrame': 'Day 0', 'description': 'will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000'}, {'measure': 'Changes in microcirculation', 'timeFrame': 'Day 28', 'description': 'will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000'}, {'measure': 'Changes in microcirculation', 'timeFrame': 'Day 42', 'description': 'will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000'}, {'measure': 'Changes in microcirculation', 'timeFrame': 'Day 70', 'description': 'will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 0', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 14', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 28', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 29', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 42', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 56', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 70', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)', 'timeFrame': 'Day 71', 'description': 'will be measured by qPCR'}, {'measure': 'Changes in body composition', 'timeFrame': 'Day 0', 'description': 'will be determined using bioelectric impendence analysis, Quad Scan.'}, {'measure': 'Changes in body composition', 'timeFrame': 'Day 28', 'description': 'will be determined using bioelectric impendence analysis, Quad Scan.'}, {'measure': 'Changes in body composition', 'timeFrame': 'Day 42', 'description': 'will be determined using bioelectric impendence analysis, Quad Scan.'}, {'measure': 'Changes in body composition', 'timeFrame': 'Day 70', 'description': 'will be determined using bioelectric impendence analysis, Quad Scan.'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 0', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 14', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 28', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 29', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 42', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 56', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 70', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Changes of the microbiota (stool samples)', 'timeFrame': 'day 71', 'description': 'will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA'}, {'measure': 'Food statement at inclusion', 'timeFrame': 'day 0', 'description': 'using 3 days food log before day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolomics', 'Plant Proteins, Dietary', 'Meat Proteins', 'Dietary Proteins', 'Metabolic Syndrome', 'Hypertriglyceridemia', 'Waist Circumference'], 'conditions': ['Metabolic Syndrome', 'Hypertriglyceridemia', 'Fasting Blood Sugar Above Normal', 'Lower Than Standard HDL-cholesterol Level', 'Slightly Elevated Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '39454458', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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).', 'detailedDescription': 'The main objectives of this project are:\n\n* Characterize the metabolic adaptations induced by animal or plant protein diets and their repercussions in terms of physiology and health.\n* Characterize the medium-term metabolomic signatures induced by this shift in dietary protein sources\n* Validate, in a human population, biomarkers of dietary animal or plant proteins, previously identified in pre-clinical studies.\n\nThis clinical trial is open, monocentric, controlled, randomized, with a cross experimental design.\n\n20 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.\n\nAt 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.\n\nThe order in which participants will received the two diets will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 35 kh/m² (terminals included)\n* Waist circumference ≥ 94 cm for men and ≥80 cm for women\n* 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 .\n\nExclusion Criteria:\n\n* Systolic blood pressure \\> 150mmHg or diastolic blood pressure \\> 90mmHg\n* pathology and medical treatment\n* diabetes\n* Smoking \\> 4 cigarettes /day\n* Alcohol consumption \\> 2 glasses/day\n* Antibiotics taken during the last 3 months before the clinical trial\n* Specific diets'}, 'identificationModule': {'nctId': 'NCT04236518', 'acronym': 'ProVegOmics', 'briefTitle': 'Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers', 'orgStudyIdInfo': {'id': 'RBHP 2019 PICKERING 2'}, 'secondaryIdInfos': [{'id': '2019-A02447-50', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source', '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', 'interventionNames': ['Behavioral: Diets with either predominantly animal protein sources.']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source', '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', 'interventionNames': ['Behavioral: Diets with predominantly plant protein sources']}], 'interventions': [{'name': 'Diets with either predominantly animal protein sources.', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/animal protein source']}, {'name': 'Diets with predominantly plant protein sources', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Hypertriglyceridimic/blood sugar/HDLcholesterol/blood pressure waist phenotype/plant protein source']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Gisèle Pickering', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes', 'class': 'UNKNOWN'}, {'name': 'UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}