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Completed

NCT Number: NCT04236518

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

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).

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Key information

Conditions

Metabolic Syndrome Dyslipidemias Fasting Blood Sugar Above Normal Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertriglyceridemia Insulin Resistance Lipid Metabolism Disorders Lower Than Standard HDL-cholesterol Level Metabolic Diseases Nutritional and Metabolic Diseases Slightly Elevated Blood Pressure

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .

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

Treatment and study plan

Diets with either predominantly animal protein sources.

Behavioral

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 sources

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • UMR 0914, Physiologie de la Nutrition et du Comportement Alimentaire, AgroParistech (adresse si besoin: 16 rue Claude Bernard, 75231 Paris Cedex 05).
  • UMR 1019, Unité de Nutrition Humaine, INRA, Centre Auvergne-Rhône Alpes

Registry information

Official study title

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

Acronym: ProVegOmics

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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