Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Calpro
研究概览
简要总结
The aim of this study is to reveal how different forms of milk casein, lactose and moderate breakdown of proteins affect the symptoms that may arise from milk and markers of inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main causative agent of stomach symptoms in milk-sensitive individuals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Perceive disturbing gut symptoms from regular milk
- •Commits to the research diet for the whole research period
- •Age: 18-65
- •BMI: 18.5-30
- •Healthy (normal kidney, liver and thyroid function and self-reported)
排除标准
- •Milk allergy
- •Regular medication (other than contraceptives) or medication affecting the gut
- •Recent course of antibiotics (< 3 months prior the study)
- •Pregnancy or lactation
- •Diagnosed bowel disease
结局指标
主要结局
Calpro
时间窗: day 4
Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut.
Gastrointestinal symptoms
时间窗: day 0 - day 3
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is divided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.
Inflammation markers
时间窗: day 4
Differences in inflammation markers (from plasma) are measured as a baseline before the study and then after each study arm.
Stool quality and defecation regularity
时间窗: day 0 - day 3
Stool quality and defecation regularity are self-reported with Bristol scale during the consumption of milks.
次要结局
未报告次要终点
研究者
Kaisa Linderborg
Principal Investigator
University of Turku