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临床试验/NCT04236518
NCT04236518已完成不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
changes of blood metabolomics

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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 .

排除标准

  • •Systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
  • •pathology and medical treatment
  • •Smoking > 4 cigarettes /day
  • •Alcohol consumption > 2 glasses/day
  • •Antibiotics taken during the last 3 months before the clinical trial
  • •Specific diets

研究组 & 干预措施

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

干预措施: Diets with predominantly plant protein sources (Behavioral)

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

干预措施: Diets with either predominantly animal protein sources. (Behavioral)

结局指标

主要结局

changes of blood metabolomics

时间窗: day 71

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 0

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 14

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 28

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 29

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 42

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 56

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

changes of blood metabolomics

时间窗: day 70

the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry

次要结局

  • Measure of lipogenesis de novo by isotopic labelling(Day 71)
  • Changes in vascular function(Day 70)
  • Changes of urine metabolomics(day 71)
  • Changes in blood glucose(day 71)
  • Changes in blood insulin(day 71)
  • Changes in blood cholesterol(day 71)
  • Changes in blood triglycerides(day 71)
  • changes in blood IL-6(day 71)
  • measure of protein synthesis by isotopic labelling(Day 71)
  • changes in blood IL-10(day 71)
  • changes in blood CRP(Day 71)
  • Changes in microcirculation(Day 70)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 71)
  • Changes in body composition(Day 70)
  • Changes of the microbiota (stool samples)(day 71)
  • Food statement at inclusion(day 0)
  • Changes of urine metabolomics(day 0)
  • Changes of urine metabolomics(day 14)
  • Changes of urine metabolomics(day 28)
  • Changes of urine metabolomics(day 29)
  • Changes of urine metabolomics(day 42)
  • Changes of urine metabolomics(day 56)
  • Changes of urine metabolomics(day 70)
  • Changes in blood glucose(day 0)
  • Changes in blood glucose(day 14)
  • Changes in blood glucose(day 28)
  • Changes in blood glucose(day 29)
  • Changes in blood glucose(day 42)
  • Changes in blood glucose(day 56)
  • Changes in blood glucose(day 70)
  • Changes in blood insulin(day 0)
  • Changes in blood insulin(day 14)
  • Changes in blood insulin(day 28)
  • Changes in blood insulin(day 29)
  • Changes in blood insulin(day 42)
  • Changes in blood insulin(day 56)
  • Changes in blood insulin(day 70)
  • Changes in blood cholesterol(day 0)
  • Changes in blood cholesterol(day 14)
  • Changes in blood cholesterol(day 28)
  • Changes in blood cholesterol(day 29)
  • Changes in blood cholesterol(day 42)
  • Changes in blood cholesterol(day 56)
  • Changes in blood cholesterol(day 70)
  • Changes in blood triglycerides(day 0)
  • Changes in blood triglycerides(day 14)
  • Changes in blood triglycerides(day 28)
  • Changes in blood triglycerides(day 29)
  • Changes in blood triglycerides(day 42)
  • Changes in blood triglycerides(day 56)
  • Changes in blood triglycerides(day 70)
  • changes in blood IL-6(day 0)
  • changes in blood IL-6(day 14)
  • changes in blood IL-6(day 28)
  • changes in blood IL-6(day 29)
  • changes in blood IL-6(day 42)
  • changes in blood IL-6(day 56)
  • changes in blood IL-6(day 70)
  • changes in blood IL-10(day 0)
  • changes in blood IL-10(day 14)
  • changes in blood IL-10(day 28)
  • changes in blood IL-10(day 29)
  • changes in blood IL-10(day 42)
  • changes in blood IL-10(day 56)
  • changes in blood IL-10(day 70)
  • changes in blood CRP(Day 0)
  • changes in blood CRP(Day 14)
  • changes in blood CRP(Day 28)
  • changes in blood CRP(Day 29)
  • changes in blood CRP(Day 42)
  • changes in blood CRP(Day 56)
  • changes in blood CRP(Day 70)
  • measure of protein synthesis by isotopic labelling(Day 28)
  • measure of protein synthesis by isotopic labelling(Day 29)
  • measure of protein synthesis by isotopic labelling(Day 70)
  • Measure of lipogenesis de novo by isotopic labelling(Day 28)
  • Measure of lipogenesis de novo by isotopic labelling(Day 29)
  • Measure of lipogenesis de novo by isotopic labelling(Day 70)
  • Changes in vascular function(Day 0)
  • Changes in vascular function(Day 28)
  • Changes in vascular function(Day 42)
  • Changes in microcirculation(Day 0)
  • Changes in microcirculation(Day 28)
  • Changes in microcirculation(Day 42)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 0)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 14)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 28)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 29)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 42)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 56)
  • Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC)(Day 70)
  • Changes in body composition(Day 0)
  • Changes in body composition(Day 28)
  • Changes in body composition(Day 42)
  • Changes of the microbiota (stool samples)(day 0)
  • Changes of the microbiota (stool samples)(day 14)
  • Changes of the microbiota (stool samples)(day 28)
  • Changes of the microbiota (stool samples)(day 29)
  • Changes of the microbiota (stool samples)(day 42)
  • Changes of the microbiota (stool samples)(day 56)
  • Changes of the microbiota (stool samples)(day 70)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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