NCT03010904已完成不适用
The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Gastrointestinal symptoms (self reported)
研究概览
简要总结
This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.
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
- •Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported)
- •age 18-65
- •BMI 18,5 - 30
- •hemoglobin under normal range
- •fasting plasma alanine aminotransferase ALAT < 60 U/l (normal liver function)
- •fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
- •fasting plasma creatinine < 118 umol/l (normal kidney function)
排除标准
- •pace maker
- •Crohn's disease or other disease of the intestinal tract
- •intestinal operation within the last 3 months
- •difficult dysphagia
- •constipation
- •lactose intolerance
- •coeliac disease
结局指标
主要结局
Gastrointestinal symptoms (self reported)
时间窗: day 0 - day 5
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided 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.
次要结局
- Plasma glucose(20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min)
- Plasma triacylglycerols(20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min)
- Plasma insulin(20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min)
研究者
Kaisa Linderborg
Principal investigator
University of Turku
研究点 (4)
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