Milk Intolerance
Conditions
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.
Interventions
OTHERDietary intervention
The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.
Sponsors
University of Turku
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Inflammation marker IL-4 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in Inflammation markers | 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) |
| Changes from Baseline in Calprotectin | 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. |
| Changes from Baseline in Stool types and Bowel movements | 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). |
| Changes from Baseline in Gastrointestinal symptoms | 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). |
| Changes from Baseline in high-sensitivity CRP | 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. |
Countries
Finland
Outcome results
None listed