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Completed

NCT Number: NCT03010904

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

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.

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Key information

Conditions

Unidentified Gastrointestinal 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, Finland

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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 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

Treatment and study plan

Dietary Intervention

Other

Primary outcomes

  1. 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 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 outcomes

  1. Plasma triacylglycerols

    Time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min

  2. Plasma glucose

    Time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min

  3. Plasma insulin

    Time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
May 25, 2022

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.