Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk

Study Overview
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Brief Summary
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The aim of this study is to reveal how different forms of milk casein, lactose and moderate breakdown of proteins affect the symptoms that may arise from milk and markers of inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main causative agent of stomach symptoms in milk-sensitive individuals.

Official Title
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Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk

Conditions
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Milk Intolerance

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perceive disturbing gut symptoms from regular milk Commits to the research diet for the whole research period Age: 18-65 BMI: 18.5-30 Healthy (normal kidney, liver and thyroid function and self-reported) Exclusion Criteria: Milk allergy Regular medication (other than contraceptives) or medication affecting the gut Recent course of antibiotics (< 3 months prior the study) Pregnancy or lactation Diagnosed bowel 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: A2 milk + placebo<br>A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme | Other: Dietary intervention<br>* The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.<br>|
| Experimental: A2 milk+ lactase enzyme<br>A2 whole milk, 3.5% fat, heat-treated; lactase capsule | Other: Dietary intervention<br>* The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.<br>|
| Experimental: Protein-hydrolyzed A1 milk + placebo<br>Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme | Other: Dietary intervention<br>* The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is divided 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 3 | 
| Inflammation markers | Differences in inflammation markers (from plasma) are measured as a baseline before the study and then after each study arm. | day 4 | 
| Calpro | Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut. | day 4 | 
| Stool quality and defecation regularity | Stool quality and defecation regularity are self-reported with Bristol scale during the consumption of milks. | day 0 - day 3 |