The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults

Study Overview
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Brief Summary
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This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.

Official Title
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The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults

Conditions
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Unidentified Gastrointestinal 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 gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal 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 lactose intolerance coeliac disease

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: pasteurized milk<br>milk that has undergone pasteurization treatment | Other: Dietary intervention<br> <br> |
| Experimental: homogenized pasteurized milk<br>Milk that has undergone homogenization and pasteurization treatment | Other: Dietary intervention<br> <br> |
| Experimental: UHT milk<br>Milk that has undergone homogenization and ultra high temperature treatment | Other: Dietary intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms (self reported) | Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal 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 |  | 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min | 
| Plasma glucose |  | 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min | 
| Plasma insulin |  | 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min |