Centre de Recherche en Nutrition Humaine
Clermont-Ferrand, 63009, France
NCT Number: NCT04282096
There are different types of casein on the market, which differ according to their chemical or physical process of obtaining. The processes will impact structural differences in the macromolecular assembly.
The majority of caseins marketed in nutrition are casein in the form of Na caseinate or Ca caseinate.
The micellar caseins obtained by membrane filtration (physical process) are more and more used in the nutrition market.
The development of casein extraction with different structures on an industrial scale opens up other perspectives for these proteins, particularly in terms of health.
The main objective of this project is to study the postprandial kinetics of the plasma concentrations of the essential amino acids of three structurally different types of caseins.
The secondary objective is to study the speed of gastric emptying and the nutritional properties of different proteins.
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Notify Me20 year–40 year
Male
Interventional
Not applicable
Clermont-Ferrand, 63009, France
All the participants will give freely their written informed consent before their selection in the study.
Each subject will participate in 3 kinetics of 5 hours with a different product test each time, in a randomized order. A wash-out period of at least 7 days will be respected between each kinetics. The products to be tested will be in the form of a powder (25g individual sachet, including 20.1g of protein) which will be reconstituted in 250ml of water and to which 100mg of 13C sodium acetate will be added.
For each of the kinetics, blood samples, expires gasses, will be collected at different time during the kinetics. A urinary collection throughout the day of kinetics will also be performed to allow the determination of urinary nitrogen Indirect calorimetry measurements will be performed 45 minutes every hour in the postprandial period and a measurement of 45 minutes will be made when the subject is fasting. Six measurements of indirect calorimetry will be performed for each kinetic.
Finally subjects will be asked to evaluate their satiety on a visual analog scale, 15' before taking the product, then every 15' the first hour in the postprandial period and every 30 'from the 2nd hour.
The subjects will also have a tolerance questionnaire to complete with each kinetic.
At the end of the kinetics, a standardized meal, single menu, consumption ad libitum measured in double weighing will be proposed to the volunteers to evaluate their satiety
During the 3 days preceding each kinetics, the protein intake of the subjects will be controlled. The meal of each night in the evening of kinetics will be standardized and identical for each kinetics. The volunteers will complete a food survey on the 3 days of control of their diet that precede each kinetics.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
selected participant will test the 3 treatments in a random order
Time frame: before and during 300 minutes after product consumption
Maximum total plasma concentration of the essential amino acids measured during different points of the 5 hours of the kinetics (one kinetic / type of casein). One point before (basal) and several points (15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes) after the consumption of one of the 3 types of caseins
Time frame: before and during 300 minutes after product consumption
Maximum total plasma concentration of the non essential amino acids measured during different points of the 5 hours of the kinetics (one kinetic / type of casein). One point before (basal) and several points (15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes) after the consumption of one of the 3 types of caseins
Time frame: before and during 300 minutes after product consumption
Time in minutes to obtain the maximal total plasma concentration of essential amino acides
Time frame: before and during 300 minutes after product consumption
Time to obtain the maximum expired 13CO2 concentration (Tmax)
Time frame: before and during 300 minutes after product consumption
Obtaining time for gastric emptying at 50% (T 1/2)
Time frame: before and during 300 minutes after product consumption
Oxidation of substrates (lipids, proteins, carbohydrates) (g/min) by indirect respiratory calorimetry corrected for nitrogen excretion.
Time frame: from product consumption until 300 minutes after
Measured by a visual analogue scale 100mm in length with words anchored at each end, expressing the most positive and the most negative rating, were used to assess hunger, satiety, fullness, prospective food consumption.
Time frame: at 300 minutes after product consumption
Time frame: before and during 300 minutes after product consumption
Ingredia S.A.
Industry
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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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