Unidentified Stomach Discomfort Following Dairy Consumption Clinical Trial
Official title:
Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
| Verified date | January 2018 |
| Source | University of Turku |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | January 1, 2018 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - pace maker - Crohn's disease or other disease of the intestinal tract - intestinal operation within the last 3 months - difficult dysphagia - smoking - constipation |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Department of Biochemistry University of Turku | Turku |
| Lead Sponsor | Collaborator |
|---|---|
| University of Turku |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pressure in the intestinal tract | Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule. | Day 0 - Day 5 | |
| Primary | Gastrointestinal symptoms (self-reported) | 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. | Day 0 - Day 5 | |
| Secondary | Plasma triacylglycerols | 20min, 40min, 60min, 120min, 180min, 240min | ||
| Secondary | Plasma glucose | 20min, 40min, 60min, 90min, 120min, 180min, 240min | ||
| Secondary | Plasma triacylglycerols | 20min, 40min, 60min, 90min, 120min, 180min, 240min | ||
| Secondary | Plasma insulin | 20min, 40min, 60min, 90min, 120min, 180min, 240min |