Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein "NUTRALYS ® S85 Plus".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Leucine blood concentration
研究概览
简要总结
The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult male volunteers, aged over 65 or under 30
- •Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
- •Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
- •Biological assessment considered compatible with participation in the study,
- •Persons able to sign the informed consent,
- •Persons affiliated to social security scheme.
排除标准
- •Pathologies or treatments not compatible with the study
- •Food allergy or a contraindication to the consumption of the products tested
- •Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
- •Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- •Subject weighing < 55 kg,
研究组 & 干预措施
Elderly volunteers
Volunteers over 65 years old.
干预措施: Pea protein (NUTRALYS ® S85 plus) in water (Dietary Supplement)
Young volunteers
Volunteers under 30 years old
干预措施: Pea protein (NUTRALYS ® S85 plus) in water (Dietary Supplement)
Young volunteers
Volunteers under 30 years old
干预措施: Pea protein (NUTRALYS ® S85 plus) within meal (Dietary Supplement)
Young volunteers
Volunteers under 30 years old
干预措施: Whey protein in water (Dietary Supplement)
Young volunteers
Volunteers under 30 years old
干预措施: Whey protein within meal (Dietary Supplement)
Elderly volunteers
Volunteers over 65 years old.
干预措施: Pea protein (NUTRALYS ® S85 plus) within meal (Dietary Supplement)
Elderly volunteers
Volunteers over 65 years old.
干预措施: Whey protein in water (Dietary Supplement)
Elderly volunteers
Volunteers over 65 years old.
干预措施: Whey protein within meal (Dietary Supplement)
结局指标
主要结局
Leucine blood concentration
时间窗: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
次要结局
- Blood insulin concentration (μIU/ml)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
- Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
- Essential amino acids blood concentration (µmol/L)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
- Non essential amino acid blood concentration (µmol/L)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
- Blood glucose concentration (g/L)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
- Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)(0 minute before eating the test meals, then regularly until 360 minutes after ingestion.)
研究者
Ruddy Richard
Director of the Nutrition Exploration Unit, Clinical professor
Université d'Auvergne