Back to resultsLow-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Primary Purpose
Milk Intolerance
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Milk Intolerance
Eligibility Criteria
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
Sites / Locations
- Food Chemistry and Food Development, Department of Life Technologies, University of Turku
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A2 milk + placebo
A2 milk+ lactase enzyme
Protein-hydrolyzed A1 milk + placebo
Arm Description
A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme
A2 whole milk, 3.5% fat, heat-treated; lactase capsule
Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme
Outcomes
Primary Outcome Measures
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.
Inflammation markers
Differences in inflammation markers (from plasma) are measured as a baseline before the study and then after each study arm.
Calpro
Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut.
Stool quality and defecation regularity
Stool quality and defecation regularity are self-reported with Bristol scale during the consumption of milks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05305391
Brief Title
Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Official Title
Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Intolerance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A2 milk + placebo
Arm Type
Experimental
Arm Description
A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme
Arm Title
A2 milk+ lactase enzyme
Arm Type
Experimental
Arm Description
A2 whole milk, 3.5% fat, heat-treated; lactase capsule
Arm Title
Protein-hydrolyzed A1 milk + placebo
Arm Type
Experimental
Arm Description
Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms
Description
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.
Time Frame
day 0 - day 3
Title
Inflammation markers
Description
Differences in inflammation markers (from plasma) are measured as a baseline before the study and then after each study arm.
Time Frame
day 4
Title
Calpro
Description
Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut.
Time Frame
day 4
Title
Stool quality and defecation regularity
Description
Stool quality and defecation regularity are self-reported with Bristol scale during the consumption of milks.
Time Frame
day 0 - day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Food Chemistry and Food Development, Department of Life Technologies, University of Turku
City
Turku
ZIP/Postal Code
20500
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
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