Fasting Blood Sugar Above Normal, Hypertriglyceridemia, Lower Than Standard HDL-cholesterol Level, Metabolic Syndrome, Slightly Elevated Blood Pressure
Conditions
Keywords
Metabolomics, Plant Proteins, Dietary, Meat Proteins, Dietary Proteins, Metabolic Syndrome, Hypertriglyceridemia, Waist Circumference
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).
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.
Interventions
BEHAVIORALDiets 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.
BEHAVIORALDiets with predominantly plant protein sources
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.
Sponsors
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).
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of blood metabolomics | day 0 | the plasma metabolome will be determined by Liquid Chromatography - Mass Spectrometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of urine metabolomics | day 0 | the urine metabolome will be determined by Liquid Chromatography - Mass Spectrometry |
| Changes in blood glucose | day 0 | The glucose concentrations will be determined by the blood samples taken by ELISA |
| Changes in blood insulin | day 0 | The insulin concentrations will be determined in the blood samples and measured by ELISA |
| Changes in blood cholesterol | day 0 | The cholesterol concentrations will be determined in the blood samples taken |
| Changes in blood triglycerides | day 0 | The triglycerides concentrations will be determined in the blood samples taken |
| changes in blood IL-6 | day 0 | The IL-6 concentrations will be determined in the blood samples taken |
| changes in blood IL-10 | day 0 | The IL-10 concentrations will be determined in the blood samples taken |
| changes in blood CRP | Day 0 | The CRP concentrations will be determined in the blood samples taken |
| measure of protein synthesis by isotopic labelling | Day 28 | measurement of protein synthesis using deuterium labelling water |
| Measure of lipogenesis de novo by isotopic labelling | Day 28 | measurement of lipogenesis using deuterium labelling water |
| Changes in vascular function | 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 |
| Changes in microcirculation | Day 0 | will be determined measuring resting state and maximal flow by Flow Laser Doppler Periflux 5000 |
| Changes in mRNA (transcriptomics) derived from Peripheral Blood Monocellular Cells (PBMC) | Day 0 | will be measured by qPCR |
| Changes in body composition | Day 0 | will be determined using bioelectric impendence analysis, Quad Scan. |
| Changes of the microbiota (stool samples) | day 0 | will be determined by the identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA |
| Food statement at inclusion | day 0 | using 3 days food log before day 0 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGisèle Pickering
University Hospital, Clermont-Ferrand
Outcome results
None listed