Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults

January 12, 2018 updated by: Kaisa Linderborg, University of Turku
This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20014
        • Department of Biochemistry University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Homogenized and pasteurized milk causes stomach problems (self-reported)
  • unhomogenized and unpasteurized milk does not cause stomach 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homogenized and pasteurized milk
Milk that has undergone homogenization ans pasteurization treatment
Other: Dietary intervention
Experimental: Nonhomogenized and nonpasteurized milk
Unhomogenized and unpasteurized milk (raw milk)
Other: Dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure in the intestinal tract
Time Frame: Day 0 - Day 5
Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
Day 0 - Day 5
Gastrointestinal symptoms (self-reported)
Time Frame: Day 0 - Day 5
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided into seven types of stomach discomfort, and also includes a possibility to describe a stomach discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.
Day 0 - Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma triacylglycerols
Time Frame: 20min, 40min, 60min, 120min, 180min, 240min
20min, 40min, 60min, 120min, 180min, 240min
Plasma glucose
Time Frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma triacylglycerols
Time Frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin
Time Frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
20min, 40min, 60min, 90min, 120min, 180min, 240min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Kaisa M Linderborg, PhD, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MILK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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