Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Turku
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Pressure in the intestinal tract
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •constipation
Arms & Interventions
Homogenized and pasteurized milk
Milk that has undergone homogenization ans pasteurization treatment
Intervention: Dietary intervention (Other)
Nonhomogenized and nonpasteurized milk
Unhomogenized and unpasteurized milk (raw milk)
Intervention: Dietary intervention (Other)
Outcomes
Primary Outcomes
Pressure in the intestinal tract
Time Frame: Day 0 - Day 5
Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
Gastrointestinal symptoms (self-reported)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Kaisa Linderborg
PhD, Adjunct professor
University of Turku