<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/NCT01686113</url>
  </required_header>
  <id_info>
    <org_study_id>1205012317</org_study_id>
    <nct_id>NCT01686113</nct_id>
  </id_info>
  <brief_title>Free Fatty Acids: Short Exposure Study</brief_title>
  <official_title>Free Fatty Acids: Short Exposure Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine whether or not short, daily exposures change a person's ability to&#xD;
      detect free fatty acids in a solution by its taste. Repeated exposure should improve a&#xD;
      person's ability to detect free fatty acids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste&#xD;
      - is a relatively new area of research. Previous work suggests that subjects require an&#xD;
      average of between two and three testing sessions of approximately an hour each before they&#xD;
      can reliably detect NEFA, and the average number of visits to get the lowest threshold is&#xD;
      six. Streamlining this process is of great interest to researchers who wish to test many&#xD;
      people as quickly as possible. Other taste qualities, including umami and sweet, have shown&#xD;
      improvement in detection sensitivity in subjects that have undergone ten second exposures to&#xD;
      these taste qualities for 10 days upon subsequent re-testing. We seek to determine if the&#xD;
      same improvements can be seen with fat taste.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NEFA detection threshold</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hunger</measure>
    <time_frame>2 days</time_frame>
    <description>Visual analog scale assessment of hunger level prior to testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste descriptor</measure>
    <time_frame>10 days</time_frame>
    <description>Description of NEFA taste by participant, e.g., sour, bitter, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hypogeusia</condition>
  <arm_group>
    <arm_group_label>NEFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants swish and spit 5 mL of sucrose solution everyday for 10 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NEFA</intervention_name>
    <arm_group_label>NEFA</arm_group_label>
    <other_name>Oleic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sucrose</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good health&#xD;
&#xD;
          -  available for multiple testing visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have participated in a fat taste study in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard D Mattes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>November 20, 2014</last_update_submitted>
  <last_update_submitted_qc>November 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Richard Mattes</investigator_full_name>
    <investigator_title>Distinguished Prof Foods and Nutrition</investigator_title>
  </responsible_party>
  <keyword>Taste</keyword>
  <keyword>Fat Taste</keyword>
  <keyword>Threshold Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ageusia</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/NCT01686113
org study id: 1205012317
nct id: NCT01686113
lead sponsor: 
has dmc: Yes
This study will examine whether or not short, daily exposures change a person's ability to
      detect free fatty acids in a solution by its taste. Repeated exposure should improve a
      person's ability to detect free fatty acids.
The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste
      - is a relatively new area of research. Previous work suggests that subjects require an
      average of between two and three testing sessions of approximately an hour each before they
      can reliably detect NEFA, and the average number of visits to get the lowest threshold is
      six. Streamlining this process is of great interest to researchers who wish to test many
      people as quickly as possible. Other taste qualities, including umami and sweet, have shown
      improvement in detection sensitivity in subjects that have undergone ten second exposures to
      these taste qualities for 10 days upon subsequent re-testing. We seek to determine if the
      same improvements can be seen with fat taste.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: NEFA detection threshold
time frame: 10 days
measure: Hunger
time frame: 2 days
description: Visual analog scale assessment of hunger level prior to testing
measure: BMI
time frame: 1 day
measure: Taste descriptor
time frame: 10 days
description: Description of NEFA taste by participant, e.g., sour, bitter, etc.
arm group label: NEFA
arm group type: Experimental
description: Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.
arm group label: Control
arm group type: Active Comparator
description: Participants swish and spit 5 mL of sucrose solution everyday for 10 days.
intervention type: Other
intervention name: NEFA
arm group label: NEFA
other name: Oleic acid
intervention type: Other
intervention name: Sucrose
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard D Mattes, PhD
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Richard Mattes
investigator title: Distinguished Prof Foods and Nutrition
mesh term: Ageusia