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

Not Applicable

Completed

• Conditions: Milk Intolerance
• Interventions: Other: Dietary intervention

• Registration Number: NCT05305391
• Lead Sponsor: University of Turku

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-05-18
• Status Verified: 2023-03
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A2 milk+ lactase enzyme	Dietary intervention	A2 whole milk, 3.5% fat, heat-treated; lactase capsule
A2 milk + placebo	Dietary intervention	A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme
Protein-hydrolyzed A1 milk + placebo	Dietary intervention	Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme

Primary Outcome Measures

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

Trial Locations

Locations (1)

Food Chemistry and Food Development, Department of Life Technologies, University of Turku; 🇫🇮 Turku, Finland