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

Unidentified Gastrointestinal Discomfort Following Dairy Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010904
• Other study ID #: MILK2
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2018

Study information

• Verified date: May 2022
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Unidentified Gastrointestinal Discomfort Following Dairy Consumption

Intervention

Other:
• Dietary intervention

Locations

Country	Name	City	State
Finland	Department of Biochemistry, University of Turku	Turku
Finland	Food Chemistry, Department of Biochemistry, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 0 - day 5
Secondary	Plasma triacylglycerols		20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
Secondary	Plasma glucose		20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
Secondary	Plasma insulin		20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min