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OpenTrials
Completed

NCT Number: NCT02219126

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

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.

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Key information

Conditions

Unidentified Stomach Discomfort Following Dairy Consumption

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry University of Turku

Turku, 20014, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

Primary outcomes

  1. Pressure in the intestinal tract

    Time frame: Day 0 - Day 5

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

  2. Gastrointestinal symptoms (self-reported)

    Time frame: Day 0 - Day 5

    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.

Secondary outcomes

  1. Plasma triacylglycerols

    Time frame: 20min, 40min, 60min, 120min, 180min, 240min

  2. Plasma glucose

    Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min

  3. Plasma triacylglycerols

    Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min

  4. Plasma insulin

    Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Aug 18, 2014
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.