Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults

Not Applicable

Completed

• Conditions: Unidentified Stomach Discomfort Following Dairy Consumption
• Interventions: Other: Dietary intervention

• Registration Number: NCT02219126
• Lead Sponsor: University of Turku

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2016-03
• Status Verified: 2018-01
• Study Completion: 2018-01-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nonhomogenized and nonpasteurized milk	Dietary intervention	Unhomogenized and unpasteurized milk (raw milk)
Homogenized and pasteurized milk	Dietary intervention	Milk that has undergone homogenization ans pasteurization treatment

Primary Outcome Measures

Name	Time	Method
Pressure in the intestinal tract	Day 0 - Day 5	Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
Gastrointestinal symptoms (self-reported)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Biochemistry University of Turku; 🇫🇮 Turku, Finland