<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/NCT01721187</url>
  </required_header>
  <id_info>
    <org_study_id>VOFIO3G</org_study_id>
    <nct_id>NCT01721187</nct_id>
  </id_info>
  <brief_title>Satiety Effects on the Neural Valuation of Food</brief_title>
  <official_title>Functional Magnetic Resonance Imaging Study of the Valuation of Food as a Function of Satiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Singapore Institute for Clinical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke-NUS Graduate Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using fMRI, this study will explore the neural correlates of satiety when individuals make&#xD;
      decisions about food. The investigators will also examine individual differences in satiety&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fMRI - Willingness to Pay task (BDM auction)</measure>
    <time_frame>Fed and fasted visits (Wks 1 &amp; 2)</time_frame>
    <description>A measurement of how much participants are willing to pay for foods and non-foods, as an assay for subjective value of goods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fMRI - Monetary and Food Incentive Delay task</measure>
    <time_frame>Fed and fasted visits (Wks 1 &amp; 2)</time_frame>
    <description>A measurement of neural response to anticipating and receiving money and food rewards.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Fasting</condition>
  <condition>Fed</condition>
  <arm_group>
    <arm_group_label>Low disinhibition</arm_group_label>
    <description>fMRI during fed and fasted states</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High disinhibition</arm_group_label>
    <description>fMRI during fed and fasted states</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      (NA)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese ethnicity&#xD;
&#xD;
          -  21 to 45 years old&#xD;
&#xD;
          -  English as first language&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Have normal eyesight, or have long-sightedness or myopia within +8.0 to -8.0 diopters&#xD;
             (unless corrected by contact lenses)&#xD;
&#xD;
          -  Weigh less than 100kg with an abdominal circumference of less than 120cm&#xD;
&#xD;
          -  Non-smoker, or only smoke occasionally (less than 5 sticks a week)&#xD;
&#xD;
          -  Consume less than 2 units (200 mg) of caffeine a day&#xD;
&#xD;
          -  Consume less than 21 units of alcohol per week (e.g. 500ml 5% beer = 2.5 units, 250ml&#xD;
             14% wine = 3.5 unit)&#xD;
&#xD;
          -  Habitually sleep before 1am and wake before 9am&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On a restrictive diet (e.g., vegetarian/vegan diet)&#xD;
&#xD;
          -  History of food allergies&#xD;
&#xD;
          -  History of psychiatric or neurological disorders&#xD;
&#xD;
          -  History of chronic medical illness&#xD;
&#xD;
          -  Metal implants in or on the body (e.g. braces, dental retainers, pacemakers)&#xD;
&#xD;
          -  Shift worker&#xD;
&#xD;
          -  Claustrophobic&#xD;
&#xD;
          -  High astigmatism (high = &gt;2.00 diopters)&#xD;
&#xD;
          -  Colour-blind&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael WL Chee, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke-NUS Graduate Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Cognitive Neuroscience scanner suite</name>
      <address>
        <city>Singapore</city>
        <zip>169611</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Plassmann H, O'Doherty J, Rangel A. Orbitofrontal cortex encodes willingness to pay in everyday economic transactions. J Neurosci. 2007 Sep 12;27(37):9984-8. doi: 10.1523/JNEUROSCI.2131-07.2007.</citation>
    <PMID>17855612</PMID>
  </reference>
  <reference>
    <citation>Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.</citation>
    <PMID>10875899</PMID>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>August 4, 2015</last_update_submitted>
  <last_update_submitted_qc>August 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duke-NUS Graduate Medical School</investigator_affiliation>
    <investigator_full_name>MChee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>Satiety</keyword>
  <keyword>Willingness to Pay</keyword>
  <keyword>Incentive Delay</keyword>
  <keyword>Dietary Disinhibition</keyword>
  <!-- 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/NCT01721187
org study id: VOFIO3G
nct id: NCT01721187
lead sponsor: 
collaborator: 
has dmc: No
Using fMRI, this study will explore the neural correlates of satiety when individuals make
      decisions about food. The investigators will also examine individual differences in satiety
      effects.
observational model: Case-Control
time perspective: Cross-Sectional
measure: fMRI - Willingness to Pay task (BDM auction)
time frame: Fed and fasted visits (Wks 1 & 2)
description: A measurement of how much participants are willing to pay for foods and non-foods, as an assay for subjective value of goods.
measure: fMRI - Monetary and Food Incentive Delay task
time frame: Fed and fasted visits (Wks 1 & 2)
description: A measurement of neural response to anticipating and receiving money and food rewards.
arm group label: Low disinhibition
description: fMRI during fed and fasted states
arm group label: High disinhibition
description: fMRI during fed and fasted states
(NA)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael WL Chee, MBBS
role: Principal Investigator
affiliation: Duke-NUS Graduate Medical School
facility: 
country: Singapore
citation: Plassmann H, O'Doherty J, Rangel A. Orbitofrontal cortex encodes willingness to pay in everyday economic transactions. J Neurosci. 2007 Sep 12;27(37):9984-8. doi: 10.1523/JNEUROSCI.2131-07.2007.
PMID: 17855612
citation: Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
PMID: 10875899
responsible party type: Principal Investigator
investigator affiliation: Duke-NUS Graduate Medical School
investigator full name: MChee
investigator title: Professor