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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A2 milk + placebo | Experimental | A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme |
|
| A2 milk+ lactase enzyme | Experimental | A2 whole milk, 3.5% fat, heat-treated; lactase capsule |
|
| Protein-hydrolyzed A1 milk + placebo | Experimental | Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline in Inflammation markers | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Sciences, Department of Life Technologies, University of Turku | Turku | Turku | 20500 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40614809 | Result | 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. |
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Sensitive volunteer data may only be shared for collaborative research purposes with a separate agreement with the data owner.
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| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| after treatment (4th day) |
| Changes from Baseline in Calprotectin | 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. | after treatment (4th day) |
| Changes from Baseline in Stool types and Bowel movements | 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). | 3 days during the treatment |
| Changes from Baseline in Gastrointestinal symptoms | 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). | 3 days during the treatment |
| Changes from Baseline in high-sensitivity CRP | 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. | after treatment (4th day) |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |