An interventional study of Test meal with plant protein and Test meal with milk protein in Nutrition, Healthy and Metabolic Syndrome, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to male participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science
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).
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Test meal incorporating an optimized plant protein ingredient
Other: Test meal with plant protein
Test meal incorporating milk proteins
Other: Test meal with milk 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.
The milk protein product is a food-grade protein isolate.
Whole body protein metabolism
Body leucine flux kinetics: oxidation, protein synthesis
Time frame: 8 months (including mass spectrometry analysis and calculations)
Satiety effect
Satiety-enhancing effect of proteins, assessed using a visual analog scale
Time frame: 12 months
Evolution of blood parameters related to satiety
Plasma concentrations of glucose, insulin, ghrelin, cholecystokinin, glucagon-like-peptide (GLP1), peptide YY (PYY) and amino acids
Time frame: 12 months
Product tolerance
Product tolerance assessed by questionnaire
Time frame: 12 months
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand