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

NCT03010904 | Completed

• 1 other identifier: MILK2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Unidentified Gastrointestinal Discomfort Following Dairy Consumption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

pasteurized milk

EXPERIMENTAL

milk that has undergone pasteurization treatment

Other: Dietary intervention

homogenized pasteurized milk

EXPERIMENTAL

Milk that has undergone homogenization and pasteurization treatment

Other: Dietary intervention

UHT milk

EXPERIMENTAL

Milk that has undergone homogenization and ultra high temperature treatment

Other: Dietary intervention

Interventions

Dietary intervention OTHER

UHT milk; homogenized pasteurized milk; pasteurized milk

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (2)

Department of Biochemistry, University of Turku

Turku, 20014, Finland

Location

Food Chemistry, Department of Biochemistry, University of Turku

Turku, 20500, Finland

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Kaisa M Linderborg, PhD

  Department of Biochemistry, University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FI (2)