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

NCT02219126 | Completed

• 1 other identifier: MILK
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unidentified Stomach Discomfort Following Dairy Consumption

Outcome Measures

Primary Outcomes (2)

• Pressure in the intestinal tract

  Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.

  Day 0 - Day 5

• Gastrointestinal symptoms (self-reported)

  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 Outcomes (4)

• Plasma triacylglycerols

  20min, 40min, 60min, 120min, 180min, 240min

• Plasma glucose

  20min, 40min, 60min, 90min, 120min, 180min, 240min

• Plasma triacylglycerols

  20min, 40min, 60min, 90min, 120min, 180min, 240min

• Plasma insulin

  20min, 40min, 60min, 90min, 120min, 180min, 240min

Study Arms (2)

Homogenized and pasteurized milk

EXPERIMENTAL

Milk that has undergone homogenization ans pasteurization treatment

Other: Dietary intervention

Nonhomogenized and nonpasteurized milk

EXPERIMENTAL

Unhomogenized and unpasteurized milk (raw milk)

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Homogenized and pasteurized milk; Nonhomogenized and nonpasteurized 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 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)

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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Department of Biochemistry University of Turku

Turku, 20014, Finland

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Kaisa M Linderborg, PhD

  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: PhD, Adjunct professor

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

FI (1)