Nutritional Caracterisation of Micellar Casein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in the plasma concentrations of the essential amino acids of 3 structurally different types of caseins during postprandial kinetics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- Aged 20 to 40 years
- •BMI : 18.5-30 Kg/m2
- •Healthy (apparently free of diseases)
- •Without dietary supplement the last month
- •Without allergy, lactose intolerance or aversion for milk protein
- •Moderately physically active
- •Affiliated to National Health Insurance
- •Having provided her written informed consent
排除标准
- •Following any kind of treatment
- •Smokers (>5 cigarets/d)
- •Vegetarian, vegan
- •Individual unable to give informed consent or refusing to sign informed consent
- •Being in exclusion on the National Volunteers Data file or refusing to be registered on the National Volunteers Data file
- •Currently participating or who having got 4500€ in this year before to have participating in another clinical trial
结局指标
主要结局
Changes in the plasma concentrations of the essential amino acids of 3 structurally different types of caseins during postprandial kinetics
时间窗: 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
次要结局
- Maximum plasma concentration for non essential amino acids(before and during 300 minutes after product consumption)
- Tmax(before and during 300 minutes after product consumption)
- Measurement of gastric emptying by the 13C sodium acetate method(before and during 300 minutes after product consumption)
- gastric emptying at 50% (T 1/2)(before and during 300 minutes after product consumption)
- Thermogenic effect of proteins at different times of kinetics(before and during 300 minutes after product consumption)
- Satietogenic effect of proteins evaluated using a visual analogue scale at different times of kinetics(from product consumption until 300 minutes after)
- Tolerance of products assessed by a questionnaire(at 300 minutes after product consumption)
- Changes in the plasma concentrations of insulin at different times of kinetics(before and during 300 minutes after product consumption)
研究者
Pr Ruddy Richard
Professor, MD, PhD
Centre de Recherche en Nutrition Humaine d'Auvergne