Determination of Protein Digestibility of Whey and Zein in Ileostomates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- the ileal amino acid digestibility of Zein and Whey Protein Isolate
研究概览
简要总结
The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.
详细描述
Objective
This study aims to determine the digestibility of amino acids in two protein sources in men and women with normally functioning ileostomies.
Study design: Intervention study with 6 test days, testing 3 meals each twice. Study population: Eight men and women with normally functioning ileostomies will be recruited for the study.
Intervention: On six separate test days, subjects will receive a meal, consisting of a drink and biscuit. With this, two different protein containing meals, i.e. zein and whey, and a protein-free meal is tested; these three treatments are given at two occasions, thus in total 6 meals are tested. After consumption of the meal, subjects collect their digesta for nine hours.
Main study parameters/endpoints: Ileal amino acid digestibility of zein and whey protein isolate.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subject will not benefit from the study except for the contribution to scientific research. The risk of participating to this study is low, some gastrointestinal discomfort could occur. Subjects have to come to the research facility seven times, a screening visit of 1 hour, and 6 experimental days of 10 hours. Subjects will be financially compensated for participation.
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
- Single (Participant)
盲法说明
Allocation of different proteins(or no protein) is blinded from participant.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Age between 18 and 60
- •Willing to eat animal protein
- •Have a well-established and normally functioning terminal ileostomy, with stomal faeces of normal physiological consistency
- •Good general health, meaning subjects should be well-recovered from the ileostomy operation, their underlying disease should be cured or in remission and they should not have any other major health problems
排除标准
- •Taken antibiotics or medication that majorly impair small intestinal digestion and absorption within eight weeks of participating in the study.
- •Have been pregnant or breastfeeding in the last 12 months, or plan to become pregnant during the study
- •Having renal impairment, coeliac disease or diabetes
- •Drug abuse
- •Alcohol consumption of >14 units per week.
- •Having an allergy or intolerance to dairy, corn products or fructose
- •Currently taking protein supplements and would not be willing to stop using these during the study
- •Being on a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study
- •Personnel of division of Human Nutrition, Wageningen University..
- •Current participation in other research from the Division of Human Nutrition
- •Not having a general practitioner
结局指标
主要结局
the ileal amino acid digestibility of Zein and Whey Protein Isolate
时间窗: 9 hours per day
ileal digesta samples are collected in the nine hours after consumption of these proteins and after consumption of a protein-free diet.
次要结局
未报告次要终点
研究者
Geleijnse
Prof. Dr.
Wageningen University