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Completed

NCT Number: NCT05305391

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Sciences, Department of Life Technologies, University of Turku

Turku, 20500, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. Changes from baseline in Inflammation marker IL-4

    Time frame: after treatment (4th day)

    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

Secondary outcomes

  1. Changes from Baseline in Inflammation markers

    Time frame: after treatment (4th day)

    Inflammation markers of 45 different proteins, such as interleukins, interferons, chemokines and growth factors are measured from fasting plasma samples as a baseline before the study and then on the 4th day after each 3-day study arm. The absolute quantities of the markers will be analysed with Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden). Differences in inflammation markers (from plasma)

  2. Changes from Baseline in Calprotectin

    Time frame: after treatment (4th day)

    Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut. Participants collect the first stool of the day in a collection tube and bring it to the study facility in a cooled bag after each study arm.

  3. Changes from Baseline in Stool types and Bowel movements

    Time frame: 3 days during the treatment

    The changes in bowel movements and stool consistency are recorded using a defecation record with the 7-step Bristol stool chart during the consumption of milks (on each study arm). Participant will record the time of the bowel movement and the dominant type of the stool. The Bristol types will be categorized as hard (types 1 and 2), normal (types 3, 4, and 5), or loose stools (types 6 and 7).

  4. Changes from Baseline in Gastrointestinal symptoms

    Time frame: 3 days during the treatment

    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. Participants fill the questionnaire during 3 days on the baseline and on each study arm (treatment).

  5. Changes from Baseline in high-sensitivity CRP

    Time frame: after treatment (4th day)

    Inflammation marker high-sensitivity CRP is measured from fasting plasma samples as a baseline before the study and then on the 4th day after each 3-day study arm.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

Low-grade Inflammation and Gut Symptoms From A2 and Protein-hydrolysed Lactose-free A1 Milk in Lactose-tolerant and Lactose-intolerant Volunteers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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