<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/NCT02264951</url>
  </required_header>
  <id_info>
    <org_study_id>SFAS</org_study_id>
    <nct_id>NCT02264951</nct_id>
  </id_info>
  <brief_title>Fat-induced Release of GLP-1 in Humans</brief_title>
  <official_title>Short Fatty Acids-induced Release of GLP-1 in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of&#xD;
      20 ml olive oil on a molar basis in human volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon&#xD;
      digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG),&#xD;
      may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty&#xD;
      acid receptors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plasma GLP-1</measure>
    <time_frame>2 hours postprandial</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>plasma GIP</measure>
    <time_frame>2 hours postprandial</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>plasma insulin</measure>
    <time_frame>2 hours postprandial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma PYY</measure>
    <time_frame>2 hours postprandial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma glucose</measure>
    <time_frame>2 hours postprandial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma neurotensin</measure>
    <time_frame>2 hour postprandial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma CCK</measure>
    <time_frame>2 hour postprandial</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>A meal containing carrot and tributyrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A meal containing carrot and C8-diet oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A meal containing carrot and olive oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A meal containing carrot</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tributyrin</intervention_name>
    <description>a triglyceride containing three C4-acids</description>
    <arm_group_label>A meal containing carrot and tributyrin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>C8-diet oil</intervention_name>
    <description>a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position</description>
    <arm_group_label>A meal containing carrot and C8-diet oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Olive oil</intervention_name>
    <description>a triglyceride containing mostly three oleic acids</description>
    <arm_group_label>A meal containing carrot and olive oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carrot</intervention_name>
    <description>mainly water and glucose</description>
    <arm_group_label>A meal containing carrot</arm_group_label>
    <arm_group_label>A meal containing carrot and C8-diet oil</arm_group_label>
    <arm_group_label>A meal containing carrot and olive oil</arm_group_label>
    <arm_group_label>A meal containing carrot and tributyrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian healthy male subjects&#xD;
&#xD;
          -  Body mass index (BMI) 19 to 25 kg/m2&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anaemia&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Gastrointestinal diseases or operations interacting with intestinal absorption&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens J Holst, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Biomedical Sciences, University of Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mette J Mandøe, Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glostrup Hospital; Biomedical Sciences, University of Copenhagen</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Katrine Bagge Hansen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Short fatty acids</keyword>
  <keyword>2-oleoyl glycerol</keyword>
  <keyword>GLP-1 secretion</keyword>
  <keyword>C8-diet oil</keyword>
  <keyword>GIP secretion</keyword>
  <!-- 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/NCT02264951
org study id: SFAS
nct id: NCT02264951
lead sponsor: 
collaborator: 
has dmc: No
This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of
      20 ml olive oil on a molar basis in human volunteers.
A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon
      digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG),
      may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty
      acid receptors.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: plasma GLP-1
time frame: 2 hours postprandial
measure: plasma GIP
time frame: 2 hours postprandial
measure: plasma insulin
time frame: 2 hours postprandial
measure: plasma PYY
time frame: 2 hours postprandial
measure: plasma glucose
time frame: 2 hours postprandial
measure: plasma neurotensin
time frame: 2 hour postprandial
measure: plasma CCK
time frame: 2 hour postprandial
arm group label: A meal containing carrot and tributyrin
arm group type: Active Comparator
description: A meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial
arm group label: A meal containing carrot and C8-diet oil
arm group type: Active Comparator
description: A meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial
arm group label: A meal containing carrot and olive oil
arm group type: Active Comparator
description: A meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial
arm group label: A meal containing carrot
arm group type: Placebo Comparator
description: A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial
intervention type: Dietary Supplement
intervention name: Tributyrin
description: a triglyceride containing three C4-acids
arm group label: A meal containing carrot and tributyrin
intervention type: Dietary Supplement
intervention name: C8-diet oil
description: a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position
arm group label: A meal containing carrot and C8-diet oil
intervention type: Dietary Supplement
intervention name: Olive oil
description: a triglyceride containing mostly three oleic acids
arm group label: A meal containing carrot and olive oil
intervention type: Dietary Supplement
intervention name: Carrot
description: mainly water and glucose
arm group label: A meal containing carrot
arm group label: A meal containing carrot and C8-diet oil
arm group label: A meal containing carrot and olive oil
arm group label: A meal containing carrot and tributyrin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jens J Holst, Professor
role: Study Chair
affiliation: Biomedical Sciences, University of Copenhagen
last name: Mette J Mandøe, Student
role: Principal Investigator
affiliation: Glostrup Hospital; Biomedical Sciences, University of Copenhagen
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Katrine Bagge Hansen
investigator title: MD, PhD