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

NCT05305391 | Completed

• 1 other identifier: MILK3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Inflammation marker IL-4

  IL-4 (interleukin 4) is measured from fasting plasma samples at the baseline before the study and then after each 3-day study arm on the 4th day. It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation. Differences in plasma inflammation marker is measured as a baseline

  after treatment (4th day)

Secondary Outcomes (5)

• Changes from Baseline in Inflammation markers

  after treatment (4th day)

• Changes from Baseline in Calprotectin

  after treatment (4th day)

• Changes from Baseline in Stool types and Bowel movements

  3 days during the treatment

• Changes from Baseline in Gastrointestinal symptoms

  3 days during the treatment

• Changes from Baseline in high-sensitivity CRP

  after treatment (4th day)

Study Arms (3)

A2 milk + placebo

EXPERIMENTAL

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

Other: Dietary intervention

A2 milk+ lactase enzyme

EXPERIMENTAL

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

Other: Dietary intervention

Protein-hydrolyzed A1 milk + placebo

EXPERIMENTAL

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

Other: Dietary intervention

Interventions

Dietary intervention OTHER

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

A2 milk + placebo; A2 milk+ lactase enzyme; Protein-hydrolyzed A1 milk + placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Food Sciences, Department of Life Technologies, University of Turku

Turku, Turku, 20500, Finland

Location

Related Publications (1)

• Mannila E, Hokkanen L, Ahonen E, Turpeinen AM, Kalliomaki M, Kortesniemi M, Linderborg KM. Tolerance of protein-hydrolyzed lactose-free A1 milk and A2 milk in lactose-tolerant and lactose-intolerant volunteers: A randomized crossover trial with 2 parallel groups. J Dairy Sci. 2025 Sep;108(9):9062-9077. doi: 10.3168/jds.2025-26712. Epub 2025 Jul 3.

  PMID: 40614809 RESULT

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: May 18, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: April 29, 2026

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)