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

University of Turku

Status: Completed

Conditions: Milk Intolerance

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05305391

MILK3

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups

A2 milk + placebo

Experimental group

Description:

A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme

Treatment:

Other: Dietary intervention

A2 milk+ lactase enzyme

Experimental group

Description:

A2 whole milk, 3.5% fat, heat-treated; lactase capsule

Treatment:

Other: Dietary intervention

Protein-hydrolyzed A1 milk + placebo

Experimental group

Description:

Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme

Treatment:

Other: Dietary intervention