<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/NCT02984150</url>
  </required_header>
  <id_info>
    <org_study_id>S55265</org_study_id>
    <nct_id>NCT02984150</nct_id>
  </id_info>
  <brief_title>Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity</brief_title>
  <official_title>Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to investigate the influence of intragastrically infused fatty acid on the&#xD;
      generalization of responses to reward within the food domain and between financial and sexual&#xD;
      domains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Earlier research at the Faculty of Economics and Business (FEB) has demonstrated&#xD;
      generalization of reward sensitivity after sensory stimulation in a different domain. As&#xD;
      increased sensory stimulation in the sexual domain (Van den Bergh et al. 2008) or the power&#xD;
      domain (Briers et al. 2007), the preference for immediate small financial reward increased&#xD;
      deferred pay. Hongda, DeWitte &amp; Warlop (2008) were able to neutralize this effect by&#xD;
      domain-specific financial satiation. In this research, The investigators investigate the&#xD;
      possible influence of (subliminal) intragastric administration of fatty acids in reward&#xD;
      sensitivity in the power domain, and whether this effect generalizes to financial and sexual&#xD;
      domain. Previous research at the Translational Research Center for Gastrointestinal Disorders&#xD;
      (TARGID) showed that such administration can neutralize the effects of mood-priming (Van&#xD;
      Oudenhove et al., 2011). This study aims to examine the implications of those findings in the&#xD;
      motivational domain.&#xD;
&#xD;
      60 healthy heterosexual men come to the lab twice, once for the fatty acid condition, once&#xD;
      for the control condition (counterbalanced, and randomly assigned to sequence condition). In&#xD;
      each session the same dv's are measured (first three tasks counterbalanced, progressive ratio&#xD;
      task always at the end). At the end of the second session, participants also compete a series&#xD;
      of interindividual difference measures (scales).&#xD;
&#xD;
      This research forms the start of a collaboration between TARGID and the Center for Research&#xD;
      in Marketing and Consumer Science at KU Leuven Faculty of Business and Economics. The current&#xD;
      paradigm is largely based on an earlier study by Prof. Dr. Lukas Van Oudenhove showing the&#xD;
      effect of intragastric administration of an identical fatty acid solution tested for mood&#xD;
      regulation (Van Oudenhove et al., 2011). The procedure performed in this study, which is&#xD;
      placing a thin nasogastric tube is frequently used in the TARGID research and other research&#xD;
      and is absolutely proven to be safe, with no mention of any adverse reactions during numerous&#xD;
      previous studies. Similar studies by our research group had already been approved by the&#xD;
      Medical Ethics Committee, and as always sees Prof. Tack ensure that the study conducted by&#xD;
      researchers who have received adequate training and have acquired sufficient experience in&#xD;
      this specific procedure before the start of the study. The procedure can be carried out in&#xD;
      healthy volunteers in a perfectly safe manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progressive ratio task</measure>
    <time_frame>10min</time_frame>
    <description>Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>estimation task</measure>
    <time_frame>10min</time_frame>
    <description>Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>10min</time_frame>
    <description>participants rate their appetite related pictures on 100-point scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>fatty acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the nutrient that can be widely found in daily food.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>dodecanoic acid</intervention_name>
    <arm_group_label>fatty acid</arm_group_label>
    <other_name>Lauric acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>saline</intervention_name>
    <arm_group_label>saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men, self-reporting as heterosexual&#xD;
&#xD;
          -  Age: Adults (+ 17yr)&#xD;
&#xD;
          -  19 ≤ BMI ≤ 27&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must be in good health, both mental and physical. People with one or more&#xD;
             of the following self-reported items applicable, are excluded:&#xD;
&#xD;
             1. History of or current presence of:&#xD;
&#xD;
          -  Psychiatric disorders (among others, anxiety disorders, somatoform disorders, eating&#xD;
             disorders, depression, addiction-related disorders, and the like)&#xD;
&#xD;
          -  Abdominal / Thoracic Surgery (excl appendectomy or cholecystectomy)&#xD;
&#xD;
          -  Neurological, endocrine or gastrointestinal-related disorders&#xD;
&#xD;
          -  Other serious medical conditions.&#xD;
&#xD;
             2. Present the presence of:&#xD;
&#xD;
          -  Pain Symptoms&#xD;
&#xD;
          -  Use of medication that affects the function of the gastrointestinal tract and / or the&#xD;
             nervous system; psychotropic drugs or pain killers&#xD;
&#xD;
          -  A recent accident or an operation which one has not yet fully recovered.&#xD;
&#xD;
        If it is positive answer to any of these criteria, participation will not be possible.&#xD;
        These criteria are questioned in advance so that participants do not get unnecessarily turn&#xD;
        up.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals Leuven, campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Briers, B., Pandelaere, M. &amp; Warlop, L. (2007). Adding exchange to charity: A reference price explanation. Journal of Economic Psychology, 28, 15-30. doi: 10.1016/j.joep.2005.12.001.</citation>
  </reference>
  <reference>
    <citation>Lassman DJ, McKie S, Gregory LJ, Lal S, D'Amato M, Steele I, Varro A, Dockray GJ, Williams SC, Thompson DG. Defining the role of cholecystokinin in the lipid-induced human brain activation matrix. Gastroenterology. 2010 Apr;138(4):1514-24. doi: 10.1053/j.gastro.2009.12.060. Epub 2010 Jan 18.</citation>
    <PMID>20080096</PMID>
  </reference>
  <reference>
    <citation>Van den Bergh, B., Dewitte, S. &amp; Warlop, L. (2008). Bikinis instigate generalized impatience in intertemporal choice. Journal of Consumer Behavior, 35, 85-97. doi: 10.1086/525505</citation>
  </reference>
  <reference>
    <citation>Van Oudenhove L, McKie S, Lassman D, Uddin B, Paine P, Coen S, Gregory L, Tack J, Aziz Q. Fatty acid-induced gut-brain signaling attenuates neural and behavioral effects of sad emotion in humans. J Clin Invest. 2011 Aug;121(8):3094-9. doi: 10.1172/JCI46380. Epub 2011 Jul 25.</citation>
    <PMID>21785220</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Lukas Van Oudenhove</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02984150
org study id: S55265
nct id: NCT02984150
lead sponsor: 
has dmc: No
This study aim to investigate the influence of intragastrically infused fatty acid on the
      generalization of responses to reward within the food domain and between financial and sexual
      domains.
Earlier research at the Faculty of Economics and Business (FEB) has demonstrated
      generalization of reward sensitivity after sensory stimulation in a different domain. As
      increased sensory stimulation in the sexual domain (Van den Bergh et al. 2008) or the power
      domain (Briers et al. 2007), the preference for immediate small financial reward increased
      deferred pay. Hongda, DeWitte & Warlop (2008) were able to neutralize this effect by
      domain-specific financial satiation. In this research, The investigators investigate the
      possible influence of (subliminal) intragastric administration of fatty acids in reward
      sensitivity in the power domain, and whether this effect generalizes to financial and sexual
      domain. Previous research at the Translational Research Center for Gastrointestinal Disorders
      (TARGID) showed that such administration can neutralize the effects of mood-priming (Van
      Oudenhove et al., 2011). This study aims to examine the implications of those findings in the
      motivational domain.

      60 healthy heterosexual men come to the lab twice, once for the fatty acid condition, once
      for the control condition (counterbalanced, and randomly assigned to sequence condition). In
      each session the same dv's are measured (first three tasks counterbalanced, progressive ratio
      task always at the end). At the end of the second session, participants also compete a series
      of interindividual difference measures (scales).

      This research forms the start of a collaboration between TARGID and the Center for Research
      in Marketing and Consumer Science at KU Leuven Faculty of Business and Economics. The current
      paradigm is largely based on an earlier study by Prof. Dr. Lukas Van Oudenhove showing the
      effect of intragastric administration of an identical fatty acid solution tested for mood
      regulation (Van Oudenhove et al., 2011). The procedure performed in this study, which is
      placing a thin nasogastric tube is frequently used in the TARGID research and other research
      and is absolutely proven to be safe, with no mention of any adverse reactions during numerous
      previous studies. Similar studies by our research group had already been approved by the
      Medical Ethics Committee, and as always sees Prof. Tack ensure that the study conducted by
      researchers who have received adequate training and have acquired sufficient experience in
      this specific procedure before the start of the study. The procedure can be carried out in
      healthy volunteers in a perfectly safe manner.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: progressive ratio task
time frame: 10min
description: Participants click the screens to get candies. The number of clicks will be used as a measurement of eating behavior.
measure: estimation task
time frame: 10min
description: Participants rate the attractiveness of 20 rewarding food pictures, 20 female face pictures on a 1-7 point scale.
measure: VAS
time frame: 10min
description: participants rate their appetite related pictures on 100-point scale
arm group label: fatty acid
arm group type: Experimental
description: the nutrient that can be widely found in daily food.
arm group label: saline
arm group type: Sham Comparator
description: saline
intervention type: Dietary Supplement
intervention name: dodecanoic acid
arm group label: fatty acid
other name: Lauric acid
intervention type: Dietary Supplement
intervention name: saline
arm group label: saline
criteria: 
gender: Male
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
citation: Briers, B., Pandelaere, M. & Warlop, L. (2007). Adding exchange to charity: A reference price explanation. Journal of Economic Psychology, 28, 15-30. doi: 10.1016/j.joep.2005.12.001.
citation: Lassman DJ, McKie S, Gregory LJ, Lal S, D'Amato M, Steele I, Varro A, Dockray GJ, Williams SC, Thompson DG. Defining the role of cholecystokinin in the lipid-induced human brain activation matrix. Gastroenterology. 2010 Apr;138(4):1514-24. doi: 10.1053/j.gastro.2009.12.060. Epub 2010 Jan 18.
PMID: 20080096
citation: Van den Bergh, B., Dewitte, S. & Warlop, L. (2008). Bikinis instigate generalized impatience in intertemporal choice. Journal of Consumer Behavior, 35, 85-97. doi: 10.1086/525505
citation: Van Oudenhove L, McKie S, Lassman D, Uddin B, Paine P, Coen S, Gregory L, Tack J, Aziz Q. Fatty acid-induced gut-brain signaling attenuates neural and behavioral effects of sad emotion in humans. J Clin Invest. 2011 Aug;121(8):3094-9. doi: 10.1172/JCI46380. Epub 2011 Jul 25.
PMID: 21785220
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Lukas Van Oudenhove
investigator title: Professor
mesh term: Hypersensitivity
sharing ipd: No