The Effect of Oral Ingestion of Animal and Plant-based Proteins on the Somatotropic Axis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Release of Growth Hormone
研究概览
简要总结
The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control.
The main questions the study aims to answer are:
- How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?
- How are the different proteins digested and taken up from our body?
Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45 years
- •Body mass index: 18.5 < 25 kg/m2
- •Signed informed consent
排除标准
- •Use of hormonal contraceptives
- •Pregnancy or breastfeeding
- •Diabetes mellitus or any other metabolic disease that might affect the results of this study
- •Gastric surgery that affects digestion and uptake of protein
- •Any clinically significant present or past disease/condition and medication which in the investigator's opinion could interfere with the results of the trial
研究组 & 干预措施
Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo
- Study day 1: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 4: 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Placebo (Dietary Supplement)
Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein
- Study day 1: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 3: 400 ml water
- Study day 4: 0.6g isolated whey protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Whey Protein (Dietary Supplement)
Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein
- Study day 1: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 3: 400 ml water
- Study day 4: 0.6g isolated whey protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Faba Bean Protein (Dietary Supplement)
Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein
- Study day 1: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 2: 400 ml water
- Study day 3: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Pea Protein (Dietary Supplement)
Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein
- Study day 1: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 2: 400 ml water
- Study day 3: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Whey Protein (Dietary Supplement)
Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein
- Study day 1: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 2: 400 ml water
- Study day 3: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Faba Bean Protein (Dietary Supplement)
Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein
- Study day 1: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 2: 400 ml water
- Study day 3: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Placebo (Dietary Supplement)
Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein
- Study day 1: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 3: 400 ml water
- Study day 4: 0.6g isolated whey protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Pea Protein (Dietary Supplement)
Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein
- Study day 1: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 3: 400 ml water
- Study day 4: 0.6g isolated whey protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Placebo (Dietary Supplement)
Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
- Study day 1: 400 ml water
- Study day 2: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated pea protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Pea Protein (Dietary Supplement)
Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
- Study day 1: 400 ml water
- Study day 2: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated pea protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Whey Protein (Dietary Supplement)
Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
- Study day 1: 400 ml water
- Study day 2: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated pea protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Faba Bean Protein (Dietary Supplement)
Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
- Study day 1: 400 ml water
- Study day 2: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 4: 0.6g isolated pea protein/kg/body weight + 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Placebo (Dietary Supplement)
Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo
- Study day 1: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 4: 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Pea Protein (Dietary Supplement)
Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo
- Study day 1: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 4: 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Whey Protein (Dietary Supplement)
Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo
- Study day 1: 0.6g isolated pea protein/kg/body weight + 400 ml water
- Study day 2: 0.6g isolated whey protein/kg/body weight + 400 ml water
- Study day 3: 0.6g isolated faba bean protein/kg/body weight + 400 ml water
- Study day 4: 400 ml water
The fat and energy content of the drinks will be adapted using a plant based oil
干预措施: Isolated Faba Bean Protein (Dietary Supplement)
结局指标
主要结局
Release of Growth Hormone
时间窗: 0-3 hours after consumption of test drink (on all 4 study days)
The primary outcome is defined as the postprandial release of growth hormone during three hours after oral ingestion of plant-protein test drinks vs. an animal-protein test drink measured as incremental area under the curve. Growth hormone will be measured in blood samples.
次要结局
- Release of Hormones Related to the Somatotrophic Axis(0-3 hours after consumption of test drink (on all 4 study days))
- Kinetics of Amino Acid Uptake(0-3 hours after consumption of test drink (on all 4 study days))