<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/NCT04408833</url>
  </required_header>
  <id_info>
    <org_study_id>249922</org_study_id>
    <nct_id>NCT04408833</nct_id>
  </id_info>
  <brief_title>Palmitate Study - A Method Study</brief_title>
  <official_title>Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this research is to measure how toddlers burn fat after drinking milk that has&#xD;
      some fat molecules that can be tracked based on how heavy they are.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research is to measure how toddlers burn fat after drinking milk that has&#xD;
      some fat molecules that can be tracked based on how heavy they are. These molecules are not&#xD;
      dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine&#xD;
      samples or more) after drinking the fat molecules, we will be able to measure how fast your&#xD;
      toddler is sending out (excreting) these samples in the urine. This will tell us how fast&#xD;
      your toddler is using fat for energy. This will also help determine the best urine collection&#xD;
      schedule for studies using this technology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>How toddlers burn fat</measure>
    <time_frame>24 hours</time_frame>
    <description>collect urine</description>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Healthy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        10 toddlers approximately two years of age from ongoing studies or as a new participant&#xD;
        from the community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Toilet trained or not&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed metabolic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Months</minimum_age>
    <maximum_age>25 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04408833
org study id: 249922
nct id: NCT04408833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to measure how toddlers burn fat after drinking milk that has
      some fat molecules that can be tracked based on how heavy they are.
The purpose of this research is to measure how toddlers burn fat after drinking milk that has
      some fat molecules that can be tracked based on how heavy they are. These molecules are not
      dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine
      samples or more) after drinking the fat molecules, we will be able to measure how fast your
      toddler is sending out (excreting) these samples in the urine. This will tell us how fast
      your toddler is using fat for energy. This will also help determine the best urine collection
      schedule for studies using this technology.
observational model: Cohort
time perspective: Prospective
measure: How toddlers burn fat
time frame: 24 hours
description: collect urine
urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 23 Months
maximum age: 25 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor