<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/NCT03255889</url>
  </required_header>
  <id_info>
    <org_study_id>GT2016</org_study_id>
    <nct_id>NCT03255889</nct_id>
  </id_info>
  <brief_title>Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men</brief_title>
  <official_title>Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the&#xD;
      form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a&#xD;
      single center study, and the recruitment is expected to happen over a 1-2- month's period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder contributing to infertility in&#xD;
      women. PCOS is also associated with Insulin resistance (IR) occurring at a high incidence&#xD;
      rate of 50-70%. IR is a condition in which your body loses sensitivity to insulin requiring&#xD;
      higher levels of it to maintain normal glucose levels in blood which hormones production from&#xD;
      ovaries. Studies have demonstrated that the prevalence of the metabolic syndrome which is a&#xD;
      cluster of condition such as increased blood pressure, high blood sugar, excess body fat&#xD;
      around the waist, and abnormal cholesterol in women with PCOS is significantly higher than&#xD;
      that of the general population. Medications that improve insulin sensitivity, such as&#xD;
      thiazolidinediones (TZDs) and Metformin, an insulin sensitizer have been used in treating&#xD;
      women with PCOS. Metformin major side effects consist of nausea, vomiting and&#xD;
      gastrointestinal distress. TZDs are withdrawn from the market due to their adverse effect&#xD;
      profile, which includes liver toxicity, weight gain, swelling due to water retention and&#xD;
      cardiovascular diseases. As current treatment options are inadequate, there is a clinical&#xD;
      need to identify new treatment regimens with a reduced adverse effect profile to improve the&#xD;
      management of PCOS and its related metabolic syndrome.&#xD;
&#xD;
      Glyceryl Tridecanoate (GT) is a medium chain triglyceride (MCT); a form of dietary fat, which&#xD;
      has a long history of safe use in in foods, drugs, cosmetics, can even be provided via the&#xD;
      veins in individuals requiring supplemental nutrition. Decanoic acid, also known as capric&#xD;
      acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%). Importantly, the&#xD;
      published findings show that oral administration of GT, the triglyceride form of decanoic&#xD;
      acid, can improve insulin sensitivity and storage and breakdown of fat in animal models of&#xD;
      diabetes. Notably, in the investigators' recent findings, DA could reduce androgen production&#xD;
      and alleviate PCOS like symptoms in a test-induced PCOS rat model. Hence, there is a high&#xD;
      likelihood that GT can improve the management of PCOS without the undesirable side effects&#xD;
      that are observed with the thiazolidinediones.&#xD;
&#xD;
      The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the&#xD;
      form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a&#xD;
      single center study, and the recruitment is expected to happen over a 1-2- month's period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Expiry of grant funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 28, 2017</start_date>
  <completion_date type="Anticipated">March 28, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 24, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events/severe events</measure>
    <time_frame>8 to 10 days</time_frame>
    <description>Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decanoic acid</measure>
    <time_frame>3 months</time_frame>
    <description>Serum will be extracted from blood samples for measurement of decanoic acid using gas chromatography-mass spectrometry (GC/MS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyceryl Tridecanoate</intervention_name>
    <description>Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>GT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sunflower oil emulsion of equal calories.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  21 - 40 years of age&#xD;
&#xD;
          -  Healthy as determined by medical, physical examination and clinical laboratory results&#xD;
&#xD;
          -  Weigh at least 60 kg.&#xD;
&#xD;
          -  Reliable and willing to follow study procedures.&#xD;
&#xD;
          -  Able to read/ understand English&#xD;
&#xD;
          -  Given written informed consent approved by NUS and the Ethical Review Board governing&#xD;
             the site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies to coconut oil, or related compounds,&#xD;
&#xD;
          -  History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,&#xD;
             endocrine, haematological, or neurological disorders capable of significantly altering&#xD;
             the absorption, or metabolism or elimination of drugs or of constituting a risk when&#xD;
             taking the study medication or interfering with the interpretation of data.&#xD;
&#xD;
          -  History of drug abuse&#xD;
&#xD;
          -  Evidence of hepatitis B infection&#xD;
&#xD;
          -  Given a blood donation of more than 450 mL in the last 3 months or any blood donation&#xD;
             within the last month.&#xD;
&#xD;
          -  Intend to use over-the counter or prescription medication known to affect reproductive&#xD;
             or metabolic functions (e.g. hormonal pills, metformin and etc.) including steroidal&#xD;
             preparations or intend to use vitamin, mineral, herbal or dietary supplements or&#xD;
             intend to consume GT health supplements during the study&#xD;
&#xD;
          -  Participants will be advised to avoid consuming coconut oil, or palm oil or any food&#xD;
             products/ health supplements containing any of these oils during the study and 3 days&#xD;
             prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eu Leong Yong, MD &amp; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Medicine Unit, National University Health System</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University Hospital, Singapore</investigator_affiliation>
    <investigator_full_name>Obstetrics &amp; Gynaecology</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Absorption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255889
org study id: GT2016
nct id: NCT03255889
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the
      form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a
      single center study, and the recruitment is expected to happen over a 1-2- month's period.
Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder contributing to infertility in
      women. PCOS is also associated with Insulin resistance (IR) occurring at a high incidence
      rate of 50-70%. IR is a condition in which your body loses sensitivity to insulin requiring
      higher levels of it to maintain normal glucose levels in blood which hormones production from
      ovaries. Studies have demonstrated that the prevalence of the metabolic syndrome which is a
      cluster of condition such as increased blood pressure, high blood sugar, excess body fat
      around the waist, and abnormal cholesterol in women with PCOS is significantly higher than
      that of the general population. Medications that improve insulin sensitivity, such as
      thiazolidinediones (TZDs) and Metformin, an insulin sensitizer have been used in treating
      women with PCOS. Metformin major side effects consist of nausea, vomiting and
      gastrointestinal distress. TZDs are withdrawn from the market due to their adverse effect
      profile, which includes liver toxicity, weight gain, swelling due to water retention and
      cardiovascular diseases. As current treatment options are inadequate, there is a clinical
      need to identify new treatment regimens with a reduced adverse effect profile to improve the
      management of PCOS and its related metabolic syndrome.

      Glyceryl Tridecanoate (GT) is a medium chain triglyceride (MCT); a form of dietary fat, which
      has a long history of safe use in in foods, drugs, cosmetics, can even be provided via the
      veins in individuals requiring supplemental nutrition. Decanoic acid, also known as capric
      acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%). Importantly, the
      published findings show that oral administration of GT, the triglyceride form of decanoic
      acid, can improve insulin sensitivity and storage and breakdown of fat in animal models of
      diabetes. Notably, in the investigators' recent findings, DA could reduce androgen production
      and alleviate PCOS like symptoms in a test-induced PCOS rat model. Hence, there is a high
      likelihood that GT can improve the management of PCOS without the undesirable side effects
      that are observed with the thiazolidinediones.

      The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the
      form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a
      single center study, and the recruitment is expected to happen over a 1-2- month's period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence and severity of adverse events/severe events
time frame: 8 to 10 days
description: Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry
measure: Decanoic acid
time frame: 3 months
description: Serum will be extracted from blood samples for measurement of decanoic acid using gas chromatography-mass spectrometry (GC/MS)
arm group label: Active
arm group type: Active Comparator
description: Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts
arm group label: Placebo
arm group type: Placebo Comparator
description: Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts
intervention type: Drug
intervention name: Glyceryl Tridecanoate
description: Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).
arm group label: Active
other name: GT
intervention type: Other
intervention name: Placebo
description: Sunflower oil emulsion of equal calories.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eu Leong Yong, MD & PhD
role: Principal Investigator
affiliation: National University Hospital, Singapore
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: National University Hospital, Singapore
investigator full name: Obstetrics & Gynaecology
investigator title: Professor
mesh term: Polycystic Ovary Syndrome
sharing ipd: No