Metabolic Syndrome, Nutrition, Healthy
Conditions
Keywords
Protein
Brief summary
The aim of the study is to compare the use of amino acids in whole-body protein metabolism in elderly consumers at risk of metabolic syndrome, after ingestion of 2 foods differing only in the nature of their proteins (optimized blend of vegetable proteins versus milk proteins). The protocol consists in studying the postprandial evolution of protein metabolism. Two products will be tested: one based on dairy proteins, the other on an optimized blend of vegetable proteins).
Detailed description
Written consent will be obtained from subjects after they have been informed of the aims, nature and possible risks of the study. Prior to inclusion, subjects will have a medical check-up carried out in the Nutritional Exploration Unit (UEN), including an interview about personal and family history and medication taken, as well as a standard medical examination and a blood test for a biological work-up (9.5 ml). Compliance with inclusion/exclusion criteria will be verified during this examination. Subjects included in the study will come to the UEN to undergo the pre-study dietary visit and to complete the two study days of 9.5 hours each, at least two weeks apart. For each study day, volunteers will arrive in the morning with an empty stomach. Two vascular catheters will be implanted. One catheter will provide continuous intravenous infusion of a labelled amino acid (13C Leucine) for a total duration of 9.5 hours. The second catheter will be used for blood sampling (8 ml), performed on an empty stomach and then, kinetically after ingestion of one of the two study products, in the form of food prepared on site. The IV-infused tracers will be used to monitor the kinetics of leucine appearance in plasma, and to quantify amino acid utilization flows at whole-body level (protein synthesis, degradation). Blood samples will also be taken to determine aminoacidemia, glycemia, insulinemia and plasma concentrations of hormones involved in regulating food intake (grelin, cholecystokinin, Glucagon-like-peptide-1 (GLP1), peptide YY (PYY). Exhaled gases will be collected during the study days. Indirect calorimetry measurements lasting 20 minutes will be taken in the post-absorptive and post-prandial periods. Seven indirect calorimetry measurements will be taken on each study day. Finally, subjects will be asked to rate their satiety on a visual analog scale, at different times during the study days. Subjects will also be asked to complete a tolerance questionnaire on each study day. At the end of each study day, volunteers will have a snack at the study center before their departure. Any intercurrent events will be recorded in the observation notebook. Allocation of the product sequence to subjects will be carried out by a random draw (generation of a random list) before the start of the study. The volume of blood drawn per volunteer is 128 ml/study day, to which must be added 9.5 ml for the biological screening test, i.e. 265.5 ml for the entire study. During the 3 days preceding each study day, the subjects' protein intake will be monitored. Standard menus were proposed, providing 1.2 g protein/kg/d. The meal on the evening before each study day will be standardized and identical for each day. To check compliance with the dietary instructions, volunteers will complete a dietary record for the 3 days preceding each study day.
Interventions
OTHERTest meal with plant protein
The plant protein blend is made up of 5 protein ingredients for which the food grade is guaranteed: a rice protein isolate, a potato protein isolate, a lupin protein isolate, a corn protein isolate.
OTHERTest meal with milk protein
The milk protein product is a food-grade protein isolate.
Sponsors
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Caregiver)
Masking description
Participants will not know which protein ingredient is included in the test-meal.
Intervention model description
Each subject is asked to test 2 different products during 2 kinetics of 9.5 hours each. Each kinetic is separated by a wash-out period of at least 2 weeks.
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Waist circumference \> 94cm * Triglycerides \> 1.5 g/L or HDL cholesterol \< 0.4 g/L * Fasting blood glucose \< 1.26g/L * Biological profile considered compatible with study participation, * Venous status judged satisfactory by the nurses, allowing catheter placement for the study, * Individuals able to sign the informed consent form, * Persons subject to a social security scheme.
Exclusion criteria
* Subjects on special diets (vegetarian, vegan, etc.), * Subject showing a weight loss ≥ 5% in 1 month or ≥ 10% in 6 months compared to usual weight. * Subject refusing to stop taking dietary supplements for the duration of the study, * Subject refusing to consume any of the proposed products, * Subject with food allergy(ies) to one or more components of the products under study, or with a contraindication to the consumption of these products, * Subjects with a pathology or treatment (antidiabetics, hypolipidemics, corticoids, neuroleptics) judged by the investigator to be incompatible with the study, * Subjects with dysthyroidism that has not been stabilized for at least 3 months, * Subject with unstabilized hypertension for at least 3 months, * Subject with a medical and/or surgical history deemed by the investigator to be incompatible with the trial, * Subject having undergone surgery that could interfere with the study objectives (as judged by the investigating physician) in the 3 months preceding the study, * Smoking \> 5 cigarettes/day, * Alcohol \> 3 glasses/day, * Claustrophobic subject, * Person refusing to be registered with the French Ministry of Health's Fichier National des Volontaires Sains, * Major under guardianship or with limited rights, * Subject not affiliated to social security, * Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 months preceding the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole body protein metabolism | 8 months (including mass spectrometry analysis and calculations) | Body leucine flux kinetics: oxidation, protein synthesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety effect | 12 months | Satiety-enhancing effect of proteins, assessed using a visual analog scale |
| Evolution of blood parameters related to satiety | 12 months | Plasma concentrations of glucose, insulin, ghrelin, cholecystokinin, glucagon-like-peptide (GLP1), peptide YY (PYY) and amino acids |
| Product tolerance | 12 months | Product tolerance assessed by questionnaire |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed