Personal Protein Digestion Variability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Personal variability in 19 amino acid uptake kinetics
研究概览
简要总结
This study aims to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne) and to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey).
The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints will be collected via an online questionnaire.
详细描述
There is currently no information on personal protein digestion variability. We recently performed a human intervention study on protein digestibility and absorption and observed that postprandial plasma amino acid (AA) profiles from an easy digestible animal protein were highly comparable among individuals. However, the same profiles from a less digestible plant-protein source (e.g. water lentil) showed a large variability among individuals. But in order to really speak of personalized digestibility, we must be able to demonstrate that the absorption rate of an individual is reproducible. Demonstrating personal differences in AA uptake kinetics will affect the way we value (new) protein sources. Determining and quantifying individual differences in digestion and absorption will allow us to better predict nutritional value of products and diets.
The primary objective is to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne). Secondary objective is to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey).
The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints will be collected via an online questionnaire.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and women;
- •Age between 18 and 40 years;
- •Body mass index (BMI) between 18.5 and 30 kg/m2 ;
- •Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).
排除标准
- •Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system;
- •History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
- •History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
- •Kidney dysfunction (self-reported);
- •Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;
- •Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility, this will be judged by the medical supervisor;
- •Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men);
- •Reported slimming, medically prescribed or other extreme diets;
- •Use of protein supplements;
- •Not willing to give up blood donation during the study;
- •Current smokers;
- •Alcohol intake ≥4 glasses of alcoholic beverages per day;
- •Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
- •Abuse of hard drugs;
- •Not having a general practitioner;
- •Participation in another clinical trial at the same time;
- •Being an employee of the department Food, Health & Consumer Research of Wageningen Food & Biobased Research or the department of Nutrition and Health of Wageningen University.
结局指标
主要结局
Personal variability in 19 amino acid uptake kinetics
时间窗: 240 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
次要结局
- Self-reported gastro-intestinal complaints(Before dinner, second day after each study day.)
研究者
Diederik Esser
Project leader clinical trials
Wageningen University and Research