<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219126</url>
  </required_header>
  <id_info>
    <org_study_id>MILK</org_study_id>
    <nct_id>NCT02219126</nct_id>
  </id_info>
  <brief_title>Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults</brief_title>
  <official_title>Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate differences in digestion rates and stomach problems caused by&#xD;
      pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible&#xD;
      capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol&#xD;
      levels and plasma cytokine levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure in the intestinal tract</measure>
    <time_frame>Day 0 - Day 5</time_frame>
    <description>Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal symptoms (self-reported)</measure>
    <time_frame>Day 0 - Day 5</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma triacylglycerols</measure>
    <time_frame>20min, 40min, 60min, 120min, 180min, 240min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>20min, 40min, 60min, 90min, 120min, 180min, 240min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma triacylglycerols</measure>
    <time_frame>20min, 40min, 60min, 90min, 120min, 180min, 240min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin</measure>
    <time_frame>20min, 40min, 60min, 90min, 120min, 180min, 240min</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Unidentified Stomach Discomfort Following Dairy Consumption</condition>
  <arm_group>
    <arm_group_label>Homogenized and pasteurized milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Milk that has undergone homogenization ans pasteurization treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonhomogenized and nonpasteurized milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unhomogenized and unpasteurized milk (raw milk)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <arm_group_label>Homogenized and pasteurized milk</arm_group_label>
    <arm_group_label>Nonhomogenized and nonpasteurized milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Homogenized and pasteurized milk causes stomach problems (self-reported)&#xD;
&#xD;
          -  unhomogenized and unpasteurized milk does not cause stomach problems (self-reported)&#xD;
&#xD;
          -  age 18-65&#xD;
&#xD;
          -  BMI 18,5 - 30&#xD;
&#xD;
          -  hemoglobin under normal range&#xD;
&#xD;
          -  fasting plasma alanine aminotransferase ALAT &lt; 60 U/l (normal liver function)&#xD;
&#xD;
          -  fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid&#xD;
             function)&#xD;
&#xD;
          -  fasting plasma creatinine &lt; 118 umol/l (normal kidney function)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pace maker&#xD;
&#xD;
          -  Crohn's disease or other disease of the intestinal tract&#xD;
&#xD;
          -  intestinal operation within the last 3 months&#xD;
&#xD;
          -  difficult dysphagia&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  constipation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaisa M Linderborg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Biochemistry University of Turku</name>
      <address>
        <city>Turku</city>
        <zip>20014</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Kaisa Linderborg</investigator_full_name>
    <investigator_title>PhD, Adjunct professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219126
org study id: MILK
nct id: NCT02219126
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pressure in the intestinal tract
time frame: Day 0 - Day 5
description: Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
measure: Gastrointestinal symptoms (self-reported)
time frame: Day 0 - Day 5
description: 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.
measure: Plasma triacylglycerols
time frame: 20min, 40min, 60min, 120min, 180min, 240min
measure: Plasma glucose
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma triacylglycerols
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma insulin
time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
arm group label: Homogenized and pasteurized milk
arm group type: Experimental
description: Milk that has undergone homogenization ans pasteurization treatment
arm group label: Nonhomogenized and nonpasteurized milk
arm group type: Experimental
description: Unhomogenized and unpasteurized milk (raw milk)
intervention type: Other
intervention name: Dietary intervention
arm group label: Homogenized and pasteurized milk
arm group label: Nonhomogenized and nonpasteurized milk
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaisa M Linderborg, PhD
role: Principal Investigator
affiliation: University of Turku
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Kaisa Linderborg
investigator title: PhD, Adjunct professor