This trial is active, not recruiting.

Condition unidentified stomach discomfort following dairy consumption
Treatment dietary intervention
Sponsor University of Turku
Start date August 2014
End date March 2016
Trial size 11 participants
Trial identifier NCT02219126, MILK


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Milk that has undergone homogenization ans pasteurization treatment
dietary intervention
Unhomogenized and unpasteurized milk (raw milk)
dietary intervention

Primary Outcomes

Pressure in the intestinal tract
time frame: Day 0 - Day 5
Gastrointestinal symptoms (self-reported)
time frame: Day 0 - Day 5

Secondary Outcomes

Plasma triacylglycerols
time frame: 20min, 40min, 60min, 120min, 180min, 240min
Plasma glucose
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma triacylglycerols
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
Principal investigator Kaisa M Linderborg, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Turku.