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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unidentified Stomach Discomfort Following Dairy Consumption

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homogenized and pasteurized milk<br>Milk that has undergone homogenization ans pasteurization treatment | Other: Dietary intervention<br> <br> |
| Experimental: Nonhomogenized and nonpasteurized milk<br>Unhomogenized and unpasteurized milk (raw milk) | Other: Dietary intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure in the intestinal tract | Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule. | Day 0 - Day 5 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma triacylglycerols |  | 20min, 40min, 60min, 120min, 180min, 240min | 
| Plasma glucose |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min | 
| Plasma triacylglycerols |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min | 
| Plasma insulin |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min |