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The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults

Primary Purpose

Unidentified Gastrointestinal Discomfort Following Dairy Consumption

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Unidentified Gastrointestinal Discomfort Following Dairy Consumption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported)
  • age 18-65
  • BMI 18,5 - 30
  • hemoglobin under normal range
  • fasting plasma alanine aminotransferase ALAT < 60 U/l (normal liver function)
  • fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
  • fasting plasma creatinine < 118 umol/l (normal kidney function)

Exclusion Criteria:

  • pace maker
  • Crohn's disease or other disease of the intestinal tract
  • intestinal operation within the last 3 months
  • difficult dysphagia
  • smoking
  • constipation
  • lactose intolerance
  • coeliac disease

Sites / Locations

  • Department of Biochemistry, University of Turku
  • Food Chemistry, Department of Biochemistry, University of Turku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

pasteurized milk

homogenized pasteurized milk

UHT milk

Arm Description

milk that has undergone pasteurization treatment

Milk that has undergone homogenization and pasteurization treatment

Milk that has undergone homogenization and ultra high temperature treatment

Outcomes

Primary Outcome Measures

Gastrointestinal symptoms (self reported)
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided 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.

Secondary Outcome Measures

Plasma triacylglycerols
Plasma glucose
Plasma insulin

Full Information

First Posted
January 4, 2017
Last Updated
May 24, 2022
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT03010904
Brief Title
The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Official Title
The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unidentified Gastrointestinal Discomfort Following Dairy Consumption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pasteurized milk
Arm Type
Experimental
Arm Description
milk that has undergone pasteurization treatment
Arm Title
homogenized pasteurized milk
Arm Type
Experimental
Arm Description
Milk that has undergone homogenization and pasteurization treatment
Arm Title
UHT milk
Arm Type
Experimental
Arm Description
Milk that has undergone homogenization and ultra high temperature treatment
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms (self reported)
Description
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided 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 5
Secondary Outcome Measure Information:
Title
Plasma triacylglycerols
Time Frame
20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
Title
Plasma glucose
Time Frame
20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
Title
Plasma insulin
Time Frame
20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min

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: Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported) age 18-65 BMI 18,5 - 30 hemoglobin under normal range fasting plasma alanine aminotransferase ALAT < 60 U/l (normal liver function) fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function) fasting plasma creatinine < 118 umol/l (normal kidney function) Exclusion Criteria: pace maker Crohn's disease or other disease of the intestinal tract intestinal operation within the last 3 months difficult dysphagia smoking constipation lactose intolerance coeliac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa M Linderborg, PhD
Organizational Affiliation
Department of Biochemistry, University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biochemistry, University of Turku
City
Turku
ZIP/Postal Code
20014
Country
Finland
Facility Name
Food Chemistry, Department of Biochemistry, University of Turku
City
Turku
ZIP/Postal Code
20500
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults

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