<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/NCT04437459</url>
  </required_header>
  <id_info>
    <org_study_id>HS1844</org_study_id>
    <nct_id>NCT04437459</nct_id>
  </id_info>
  <brief_title>The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test</brief_title>
  <official_title>The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oklahoma State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oklahoma State University</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>
      This study aims to evaluate the reliability of a shortened fat tolerance test (&quot;abbreviated&#xD;
      fat tolerance test&quot;, or &quot;AFTT&quot;) for measuring post-meal lipids in human blood. The&#xD;
      reliability of the triglyceride results in this test are compared to the reliability of the&#xD;
      glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically&#xD;
      accepted metabolic test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reliability of the Change in Triglycerides after a High-Fat Meal</measure>
    <time_frame>The two fat tolerance tests are separated by 1 week.</time_frame>
    <description>Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of the Change in Glucose after Ingestion of a Glucose Solution</measure>
    <time_frame>The two glucose tolerance tests are separated by 1 week.</time_frame>
    <description>Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Dyslipidemias</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Abbreviated Fat Tolerance Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Glucose Tolerance Test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-fat shake</intervention_name>
    <description>Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.</description>
    <arm_group_label>Abbreviated Fat Tolerance Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pure glucose solution</intervention_name>
    <description>Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.</description>
    <arm_group_label>Oral Glucose Tolerance Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Free of chronic disease&#xD;
&#xD;
          -  Normal (healthy) fasting glucose and triglycerides&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of pace-maker&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Using tobacco products&#xD;
&#xD;
          -  Using medications or dietary supplements that could modify primary outcomes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sam R Emerson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oklahoma State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oklahoma State University</name>
      <address>
        <city>Stillwater</city>
        <state>Oklahoma</state>
        <zip>74078-6104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Dyslipidemias</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/NCT04437459
org study id: HS1844
nct id: NCT04437459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated
      fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The
      reliability of the triglyceride results in this test are compared to the reliability of the
      glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically
      accepted metabolic test.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Reliability of the Change in Triglycerides after a High-Fat Meal
time frame: The two fat tolerance tests are separated by 1 week.
description: Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.
measure: Reliability of the Change in Glucose after Ingestion of a Glucose Solution
time frame: The two glucose tolerance tests are separated by 1 week.
description: Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.
arm group label: Abbreviated Fat Tolerance Test
arm group type: Experimental
arm group label: Oral Glucose Tolerance Test
arm group type: Active Comparator
intervention type: Other
intervention name: High-fat shake
description: Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
arm group label: Abbreviated Fat Tolerance Test
intervention type: Other
intervention name: Pure glucose solution
description: Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
arm group label: Oral Glucose Tolerance Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sam R Emerson, PhD
role: Principal Investigator
affiliation: Oklahoma State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Dyslipidemias