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

NCT ID: NCT05305391

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2023-03-03

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.

Conditions

Milk Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

A2 milk + placebo

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

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.

A2 milk+ lactase enzyme

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

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.

Protein-hydrolyzed A1 milk + placebo

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

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.

Interventions

Dietary intervention

The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Kaisa Linderborg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Food Chemistry and Food Development, Department of Life Technologies, University of Turku

Turku, , Finland

Countries

Finland

Other Identifiers

MILK3

Identifier Type: -

Identifier Source: org_study_id