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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236518
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
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).
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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).


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypertriglyceridemia Behavioral: Diets with either predominantly animal protein sources. Behavioral: Diets with predominantly plant protein sources Not Applicable

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 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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: : hypertriglyceridimic waist phenotype / animal protein source
20 men between 25 and 55 years old with a high waist circumference and high triglyceridemia receiving diets with predominantly animal protein sources
Behavioral: Diets with either predominantly animal protein sources.
20 men 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.

Experimental: hypertriglyceridimic waist phenotype / plant protein source
20 men between 25 and 55 years old with a high waist circumference and high triglyceridemia receiving diets with predominantly plant protein sources
Behavioral: Diets with predominantly plant protein sources
20 men 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.




Primary Outcome Measures :
  1. changes of blood metabolomics [ Time Frame: day 0 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  2. changes of blood metabolomics [ Time Frame: day 14 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  3. changes of blood metabolomics [ Time Frame: day 28 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  4. changes of blood metabolomics [ Time Frame: day 29 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  5. changes of blood metabolomics [ Time Frame: day 42 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  6. changes of blood metabolomics [ Time Frame: day 56 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  7. changes of blood metabolomics [ Time Frame: day 70 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  8. changes of blood metabolomics [ Time Frame: day 71 ]
    the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry


Secondary Outcome Measures :
  1. Changes of urine metabolomics [ Time Frame: day 0 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  2. Changes of urine metabolomics [ Time Frame: day 14 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  3. Changes of urine metabolomics [ Time Frame: day 28 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  4. Changes of urine metabolomics [ Time Frame: day 29 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  5. Changes of urine metabolomics [ Time Frame: day 42 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  6. Changes of urine metabolomics [ Time Frame: day 56 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  7. Changes of urine metabolomics [ Time Frame: day 70 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  8. Changes of urine metabolomics [ Time Frame: day 71 ]
    the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry

  9. Changes in blood glucose [ Time Frame: day 0 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  10. Changes in blood glucose [ Time Frame: day 14 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  11. Changes in blood glucose [ Time Frame: day 28 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  12. Changes in blood glucose [ Time Frame: day 29 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  13. Changes in blood glucose [ Time Frame: day 42 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  14. Changes in blood glucose [ Time Frame: day 56 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  15. Changes in blood glucose [ Time Frame: day 70 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  16. Changes in blood glucose [ Time Frame: day 71 ]
    The glucose concentrations will be determined by the blood samples taken by ELISA

  17. Changes in blood insulin [ Time Frame: day 0 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  18. Changes in blood insulin [ Time Frame: day 14 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  19. Changes in blood insulin [ Time Frame: day 28 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  20. Changes in blood insulin [ Time Frame: day 29 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  21. Changes in blood insulin [ Time Frame: day 42 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  22. Changes in blood insulin [ Time Frame: day 56 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  23. Changes in blood insulin [ Time Frame: day 70 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  24. Changes in blood insulin [ Time Frame: day 71 ]
    The insulin concentrations will be determined in the blood samples and measured by ELISA

  25. Changes in blood cholesterol [ Time Frame: day 0 ]
    The cholesterol concentrations will be determined in the blood samples taken

  26. Changes in blood cholesterol [ Time Frame: day 14 ]
    The cholesterol concentrations will be determined in the blood samples taken

  27. Changes in blood cholesterol [ Time Frame: day 28 ]
    The cholesterol concentrations will be determined in the blood samples taken

  28. Changes in blood cholesterol [ Time Frame: day 29 ]
    The cholesterol concentrations will be determined in the blood samples taken

  29. Changes in blood cholesterol [ Time Frame: day 42 ]
    The cholesterol concentrations will be determined in the blood samples taken

  30. Changes in blood cholesterol [ Time Frame: day 56 ]
    The cholesterol concentrations will be determined in the blood samples taken

  31. Changes in blood cholesterol [ Time Frame: day 70 ]
    The cholesterol concentrations will be determined in the blood samples taken

  32. Changes in blood cholesterol [ Time Frame: day 71 ]
    The cholesterol concentrations will be determined in the blood samples taken

  33. Changes in blood triglycerides [ Time Frame: day 0 ]
    The triglycerides concentrations will be determined in the blood samples taken

  34. Changes in blood triglycerides [ Time Frame: day 14 ]
    The triglycerides concentrations will be determined in the blood samples taken

  35. Changes in blood triglycerides [ Time Frame: day 28 ]
    The triglycerides concentrations will be determined in the blood samples taken

  36. Changes in blood triglycerides [ Time Frame: day 29 ]
    The triglycerides concentrations will be determined in the blood samples taken

  37. Changes in blood triglycerides [ Time Frame: day 42 ]
    The triglycerides concentrations will be determined in the blood samples taken

  38. Changes in blood triglycerides [ Time Frame: day 56 ]
    The triglycerides concentrations will be determined in the blood samples taken

  39. Changes in blood triglycerides [ Time Frame: day 70 ]
    The triglycerides concentrations will be determined in the blood samples taken

  40. Changes in blood triglycerides [ Time Frame: day 71 ]
    The triglycerides concentrations will be determined in the blood samples taken

  41. changes in blood IL-6 [ Time Frame: day 0 ]
    The IL-6 concentrations will be determined in the blood samples taken

  42. changes in blood IL-6 [ Time Frame: day 14 ]
    The IL-6 concentrations will be determined in the blood samples taken

  43. changes in blood IL-6 [ Time Frame: day 28 ]
    The IL-6 concentrations will be determined in the blood samples taken

  44. changes in blood IL-6 [ Time Frame: day 29 ]
    The IL-6 concentrations will be determined in the blood samples taken

  45. changes in blood IL-6 [ Time Frame: day 42 ]
    The IL-6 concentrations will be determined in the blood samples taken

  46. changes in blood IL-6 [ Time Frame: day 56 ]
    The IL-6 concentrations will be determined in the blood samples taken

  47. changes in blood IL-6 [ Time Frame: day 70 ]
    The IL-6 concentrations will be determined in the blood samples taken

  48. changes in blood IL-6 [ Time Frame: day 71 ]
    The IL-6 concentrations will be determined in the blood samples taken

  49. changes in blood IL-10 [ Time Frame: day 0 ]
    The IL-10 concentrations will be determined in the blood samples taken

  50. changes in blood IL-10 [ Time Frame: day 14 ]
    The IL-10 concentrations will be determined in the blood samples taken

  51. changes in blood IL-10 [ Time Frame: day 28 ]
    The IL-10 concentrations will be determined in the blood samples taken

  52. changes in blood IL-10 [ Time Frame: day 29 ]
    The IL-10 concentrations will be determined in the blood samples taken

  53. changes in blood IL-10 [ Time Frame: day 42 ]
    The IL-10 concentrations will be determined in the blood samples taken

  54. changes in blood IL-10 [ Time Frame: day 56 ]
    The IL-10 concentrations will be determined in the blood samples taken

  55. changes in blood IL-10 [ Time Frame: day 70 ]
    The IL-10 concentrations will be determined in the blood samples taken

  56. changes in blood IL-10 [ Time Frame: day 71 ]
    The IL-10 concentrations will be determined in the blood samples taken

  57. changes in blood CRP [ Time Frame: Day 0 ]
    The CRP concentrations will be determined in the blood samples taken

  58. changes in blood CRP [ Time Frame: Day 14 ]
    The CRP concentrations will be determined in the blood samples taken

  59. changes in blood CRP [ Time Frame: Day 28 ]
    The CRP concentrations will be determined in the blood samples taken

  60. changes in blood CRP [ Time Frame: Day 29 ]
    The CRP concentrations will be determined in the blood samples taken

  61. changes in blood CRP [ Time Frame: Day 42 ]
    The CRP concentrations will be determined in the blood samples taken

  62. changes in blood CRP [ Time Frame: Day 56 ]
    The CRP concentrations will be determined in the blood samples taken

  63. changes in blood CRP [ Time Frame: Day 70 ]
    The CRP concentrations will be determined in the blood samples taken

  64. changes in blood CRP [ Time Frame: Day 71 ]
    The CRP concentrations will be determined in the blood samples taken

  65. measure of protein synthesis by isotopic labelling [ Time Frame: Day 28 ]
    measurement of protein synthesis using deuterium labelling water

  66. measure of protein synthesis by isotopic labelling [ Time Frame: Day 29 ]
    measurement of protein synthesis using deuterium labelling water

  67. measure of protein synthesis by isotopic labelling [ Time Frame: Day 70 ]
    measurement of protein synthesis using deuterium labelling water

  68. measure of protein synthesis by isotopic labelling [ Time Frame: Day 71 ]
    measurement of protein synthesis using deuterium labelling water

  69. Measure of lipogenesis de novo by isotopic labelling [ Time Frame: Day 28 ]
    measurement of lipogenesis using deuterium labelling water

  70. Measure of lipogenesis de novo by isotopic labelling [ Time Frame: Day 29 ]
    measurement of lipogenesis using deuterium labelling water

  71. Measure of lipogenesis de novo by isotopic labelling [ Time Frame: Day 70 ]
    measurement of lipogenesis using deuterium labelling water

  72. Measure of lipogenesis de novo by isotopic labelling [ Time Frame: Day 71 ]
    measurement of lipogenesis using deuterium labelling water

  73. Changes in vascular function [ Time Frame: Day 0 ]
    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

  74. Changes in vascular function [ Time Frame: Day 28 ]
    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

  75. Changes in vascular function [ Time Frame: Day 42 ]
    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

  76. Changes in vascular function [ Time Frame: Day 70 ]
    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

  77. Changes in microcirculation [ Time Frame: Day 0 ]
    will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000

  78. Changes in microcirculation [ Time Frame: Day 28 ]
    will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000

  79. Changes in microcirculation [ Time Frame: Day 42 ]
    will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000

  80. Changes in microcirculation [ Time Frame: Day 70 ]
    will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000

  81. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 0 ]
    will be measured by qPCR

  82. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 14 ]
    will be measured by qPCR

  83. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 28 ]
    will be measured by qPCR

  84. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 29 ]
    will be measured by qPCR

  85. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 42 ]
    will be measured by qPCR

  86. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 56 ]
    will be measured by qPCR

  87. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 70 ]
    will be measured by qPCR

  88. Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) [ Time Frame: Day 71 ]
    will be measured by qPCR

  89. Changes in body composition [ Time Frame: Day 0 ]
    will be determined using bioelectric impendence analysis, Quad Scan.

  90. Changes in body composition [ Time Frame: Day 28 ]
    will be determined using bioelectric impendence analysis, Quad Scan.

  91. Changes in body composition [ Time Frame: Day 42 ]
    will be determined using bioelectric impendence analysis, Quad Scan.

  92. Changes in body composition [ Time Frame: Day 70 ]
    will be determined using bioelectric impendence analysis, Quad Scan.

  93. Changes of the microbiota (stool samples) [ Time Frame: day 0 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  94. Changes of the microbiota (stool samples) [ Time Frame: day 14 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  95. Changes of the microbiota (stool samples) [ Time Frame: day 28 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  96. Changes of the microbiota (stool samples) [ Time Frame: day 29 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  97. Changes of the microbiota (stool samples) [ Time Frame: day 42 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  98. Changes of the microbiota (stool samples) [ Time Frame: day 56 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  99. Changes of the microbiota (stool samples) [ Time Frame: day 70 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  100. Changes of the microbiota (stool samples) [ Time Frame: day 71 ]
    will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA

  101. Food statement at inclusion [ Time Frame: day 0 ]
    using 3 days food log before day 0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 25 and 30 kh/m²
  • Waist circumference > 94 cm
  • Triglyceridemia > 1.5g/L

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236518


Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE +334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Contact: Gisèle Pickering       gpickering@chu-clermontferrand.fr   
Principal Investigator: Gisèle Pickering         
Sub-Investigator: Gilles Ducheix         
Sub-Investigator: Christian Dualé         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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).
Investigators
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Principal Investigator: Gisèle Pickering University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04236518    
Other Study ID Numbers: RBHP 2019 PICKERING 2
2019-A02447-50 ( Other Identifier: ANSM )
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Metabolomics
Plant Proteins, Dietary
Meat Proteins
Dietary Proteins
Metabolic Syndrome
Hypertriglyceridemia
Waist Circumference
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Hypertriglyceridemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders