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

Milk Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305391
• Other study ID #: MILK3
• Status: Completed
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Milk Intolerance

Intervention

Other:
• Dietary intervention
The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.

Locations

Country	Name	City	State
Finland	Food Chemistry and Food Development, Department of Life Technologies, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 0 - day 3
Primary	Inflammation markers	Differences in inflammation markers (from plasma) are measured as a baseline before the study and then after each study arm.	day 4
Primary	Calpro	Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut.	day 4
Primary	Stool quality and defecation regularity	Stool quality and defecation regularity are self-reported with Bristol scale during the consumption of milks.	day 0 - day 3