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

NCT ID: NCT02219126

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Unidentified Stomach Discomfort Following Dairy Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Homogenized and pasteurized milk

Milk that has undergone homogenization ans pasteurization treatment

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Nonhomogenized and nonpasteurized milk

Unhomogenized and unpasteurized milk (raw milk)

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Interventions

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Dietary intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Kaisa Linderborg

PhD, Adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaisa M Linderborg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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Department of Biochemistry University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MILK

Identifier Type: -

Identifier Source: org_study_id

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