<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/NCT01719419</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12014</org_study_id>
    <nct_id>NCT01719419</nct_id>
  </id_info>
  <brief_title>The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects</brief_title>
  <official_title>The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the&#xD;
      taste for fat in humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One screening visit and Testing Visits 1 and 2: Approximately 1-2 hours (Fasting - You will&#xD;
      have nothing to eat or drink (except water or medications) after midnight before the test&#xD;
      visit.) If you qualify for the study, you will return to Pennington Biomedical Research&#xD;
      Center for the test visit&#xD;
&#xD;
        -  You will be given a questionnaire to screen for allergies or cold symptoms.&#xD;
&#xD;
        -  Women will answer a questionnaire based on their menstrual cycle.&#xD;
&#xD;
        -  Before eating, you will be given instructions on how to use the study medication. You&#xD;
           will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it&#xD;
           out (like mouthwash).&#xD;
&#xD;
        -  Just before eating, you will be given another brief questionnaire judging your appetite.&#xD;
&#xD;
        -  You will be given the test meal. You will be allowed to eat as much or as little as you&#xD;
           like during a 20-minute eating period.&#xD;
&#xD;
        -  30 minutes after starting your meal you will be given the brief questionnaire again to&#xD;
           judge your appetite.&#xD;
&#xD;
        -  You will return in 1 month to complete test visit 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Does orlistat decreases the taste for fatty food intake</measure>
    <time_frame>1 month</time_frame>
    <description>Before eating, you will be given instructions on how to use the study medication. You will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it out (like mouthwash).&#xD;
Just before eating, you will be given another brief questionnaire judging your appetite.&#xD;
You will be given the test meal. You will be allowed to eat as much or as little as you like during a 20-minute eating period.&#xD;
30 minutes after starting your meal you will be given the brief questionnaire again to judge your appetite.&#xD;
You will return in 1 month to complete test visit 2.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orlistat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orlistat</intervention_name>
    <description>Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.</description>
    <arm_group_label>Orlistat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are a healthy male or female,&#xD;
&#xD;
          -  Are between 18 to 70 years of age,&#xD;
&#xD;
          -  Have a body mass index between 25-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are a female who is pregnant or nursing,&#xD;
&#xD;
          -  Are a restrained eater (determined using a questionnaire),&#xD;
&#xD;
          -  Have any current illnesses such as an infection,&#xD;
&#xD;
          -  Have any serious medical problems including kidney, liver, heart or lung disease,&#xD;
&#xD;
               -  Use medications known to increase appetite,&#xD;
&#xD;
               -  Are taking any medication that has not been on the same dose for at least 30&#xD;
                  days,&#xD;
&#xD;
               -  Dislike the test food.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Frank Greenway</investigator_full_name>
    <investigator_title>Principal Investigaator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Orlistat</mesh_term>
  </intervention_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/NCT01719419
org study id: PBRC 12014
nct id: NCT01719419
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the
      taste for fat in humans.
One screening visit and Testing Visits 1 and 2: Approximately 1-2 hours (Fasting - You will
      have nothing to eat or drink (except water or medications) after midnight before the test
      visit.) If you qualify for the study, you will return to Pennington Biomedical Research
      Center for the test visit

        -  You will be given a questionnaire to screen for allergies or cold symptoms.

        -  Women will answer a questionnaire based on their menstrual cycle.

        -  Before eating, you will be given instructions on how to use the study medication. You
           will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it
           out (like mouthwash).

        -  Just before eating, you will be given another brief questionnaire judging your appetite.

        -  You will be given the test meal. You will be allowed to eat as much or as little as you
           like during a 20-minute eating period.

        -  30 minutes after starting your meal you will be given the brief questionnaire again to
           judge your appetite.

        -  You will return in 1 month to complete test visit 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Does orlistat decreases the taste for fatty food intake
time frame: 1 month
description: Before eating, you will be given instructions on how to use the study medication. You will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it out (like mouthwash).
Just before eating, you will be given another brief questionnaire judging your appetite.
You will be given the test meal. You will be allowed to eat as much or as little as you like during a 20-minute eating period.
30 minutes after starting your meal you will be given the brief questionnaire again to judge your appetite.
You will return in 1 month to complete test visit 2.
arm group label: Placebo
arm group type: Experimental
description: Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.
arm group label: Orlistat
arm group type: Experimental
description: Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.
intervention type: Drug
intervention name: Placebo
description: Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
arm group label: Placebo
intervention type: Drug
intervention name: Orlistat
description: Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.
arm group label: Orlistat
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigaator
mesh term: Overweight
mesh term: Orlistat