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

Sponsor

University of Turku (Other)

Overall Status

Completed

CT.gov ID

NCT03010904

Collaborator

(none)

Enrollment

Locations

Arms

15.9

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unidentified Gastrointestinal Discomfort Following Dairy Consumption	Other: Dietary intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pasteurized milk milk that has undergone pasteurization treatment	Other: Dietary intervention
Experimental: homogenized pasteurized milk Milk that has undergone homogenization and pasteurization treatment	Other: Dietary intervention
Experimental: UHT milk Milk that has undergone homogenization and ultra high temperature treatment	Other: Dietary intervention

Arm

Intervention/Treatment

Experimental: pasteurized milk

milk that has undergone pasteurization treatment

Other: Dietary intervention

Experimental: homogenized pasteurized milk

Milk that has undergone homogenization and pasteurization treatment

Other: Dietary intervention

Experimental: UHT milk

Milk that has undergone homogenization and ultra high temperature treatment

Other: Dietary intervention

Outcome Measures

Primary Outcome Measures

Gastrointestinal symptoms (self reported) [day 0 - day 5]
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 [20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min]
Plasma glucose [20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min]
Plasma insulin [20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biochemistry, University of Turku	Turku		Finland	20014
2	Food Chemistry, Department of Biochemistry, University of Turku	Turku		Finland	20500

Sponsors and Collaborators

University of Turku

Investigators

Principal Investigator: Kaisa M Linderborg, PhD, Department of Biochemistry, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaisa Linderborg, Principal investigator, University of Turku

ClinicalTrials.gov Identifier:

NCT03010904

Other Study ID Numbers:

MILK2

First Posted:

Jan 5, 2017

Last Update Posted:

May 25, 2022

Last Verified:

May 1, 2022

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of May 25, 2022