<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/NCT03010904</url>
  </required_header>
  <id_info>
    <org_study_id>MILK2</org_study_id>
    <nct_id>NCT03010904</nct_id>
  </id_info>
  <brief_title>The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults</brief_title>
  <official_title>The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive 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 gastrointestinal problems&#xD;
      caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's&#xD;
      milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and&#xD;
      plasma cytokine levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>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 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma triacylglycerols</measure>
    <time_frame>20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin</measure>
    <time_frame>20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Unidentified Gastrointestinal Discomfort Following Dairy Consumption</condition>
  <arm_group>
    <arm_group_label>pasteurized milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>milk that has undergone pasteurization treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>homogenized pasteurized milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Milk that has undergone homogenization and pasteurization treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UHT milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Milk that has undergone homogenization and ultra high temperature treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <arm_group_label>UHT milk</arm_group_label>
    <arm_group_label>homogenized pasteurized milk</arm_group_label>
    <arm_group_label>pasteurized milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Homogenized and pasteurized milk causes gastrointestinal problems (self-reported)&#xD;
             unhomogenized and unpasteurized milk does not cause gastrointestinal problems&#xD;
             (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;
&#xD;
          -  lactose intolerance&#xD;
&#xD;
          -  coeliac disease&#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>Department of Biochemistry, 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>
    <facility>
      <name>Food Chemistry, Department of Biochemistry, University of Turku</name>
      <address>
        <city>Turku</city>
        <zip>20500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</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>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT03010904
org study id: MILK2
nct id: NCT03010904
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 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.
measure: Plasma triacylglycerols
time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
measure: Plasma glucose
time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
measure: Plasma insulin
time frame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
arm group label: pasteurized milk
arm group type: Experimental
description: milk that has undergone pasteurization treatment
arm group label: homogenized pasteurized milk
arm group type: Experimental
description: Milk that has undergone homogenization and pasteurization treatment
arm group label: UHT milk
arm group type: Experimental
description: Milk that has undergone homogenization and ultra high temperature treatment
intervention type: Other
intervention name: Dietary intervention
arm group label: UHT milk
arm group label: homogenized pasteurized milk
arm group label: pasteurized 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: Department of Biochemistry, University of Turku
facility: 
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Kaisa Linderborg
investigator title: Principal investigator
mesh term: Hypersensitivity