Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pressure in the intestinal tract
研究概览
简要总结
This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, 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 stomach problems (self-reported)
- •unhomogenized and unpasteurized milk does not cause stomach 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
研究组 & 干预措施
Homogenized and pasteurized milk
Milk that has undergone homogenization ans pasteurization treatment
干预措施: Dietary intervention (Other)
Nonhomogenized and nonpasteurized milk
Unhomogenized and unpasteurized milk (raw milk)
干预措施: Dietary intervention (Other)
结局指标
主要结局
Pressure in the intestinal tract
时间窗: Day 0 - Day 5
Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
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 stomach discomfort, and also includes a possibility to describe a stomach discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.
次要结局
- Plasma triacylglycerols(20min, 40min, 60min, 90min, 120min, 180min, 240min)
- Plasma glucose(20min, 40min, 60min, 90min, 120min, 180min, 240min)
- Plasma insulin(20min, 40min, 60min, 90min, 120min, 180min, 240min)
- Plasma triacylglycerols(20min, 40min, 60min, 120min, 180min, 240min)
研究者
Kaisa Linderborg
PhD, Adjunct professor
University of Turku