<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/NCT02982616</url>
  </required_header>
  <id_info>
    <org_study_id>S55863</org_study_id>
    <nct_id>NCT02982616</nct_id>
  </id_info>
  <brief_title>Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects</brief_title>
  <official_title>Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Normal Weight Subjects</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>
      The purpose of this study is to test whether intragastrically infused fatty acid will&#xD;
      interact with positive emotion induction and if this effect is mediated by gut hormones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims at the possible effect of subliminal intragastric administration of fatty&#xD;
      acids on responses to positive emotion induction, based on our earlier findings that&#xD;
      subjective administration of fatty acid decreases neural responses to negative mood induction&#xD;
      (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the&#xD;
      participants sign the informed consent form, an intravenous catheter is placed in the&#xD;
      forearm, and a naso-gastric tube inserted through the nose. Then the test subject is&#xD;
      connected to the equipment in order to record the activity of the autonomic nervous system,&#xD;
      via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid&#xD;
      solution (Dodecanoic acid, &quot;fatty acid&quot; condition) or a physiological saline solution (&#xD;
      &quot;control&quot; condition) intragastrically. The intragastric administration of low doses of this&#xD;
      food ingredient has already been used in several previous studies by our research group and&#xD;
      has proven perfectly safe. A positive or neutral emotional state will be induced by the&#xD;
      combination of looking at emotional facial expressions and listening to classical music&#xD;
      pieces that were previously validated for this purpose; This combination of incentives has&#xD;
      already been used in previous studies of our research group. Responses will be measured by&#xD;
      means of validated self-report scales and measurements of the vagal tone. We also take blood&#xD;
      samples on a regular basis by the intravenous catheter for determination of gastrointestinal&#xD;
      hormones, given our hypothesis that this may explain the effect on emotions. After removal of&#xD;
      the nasogastric tube, the influence of subliminal administration of fatty acids and emotional&#xD;
      state on food intake measured by means of a validated and previously drink test used in which&#xD;
      participants &quot;ad libitum&quot; to drink a chocolate milkshake while the emotion-induction by means&#xD;
      of classical music pieces continue. Finally, the intravenous catheter is removed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>time evolution of VAS from the beginning until the end of a study visit</measure>
    <time_frame>-10min 0min 10min 20min 30min 40min</time_frame>
    <description>visual analogue scale for appetite related sensations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time evolution of gut hormones from the beginning until the end of a study visit</measure>
    <time_frame>-10min 10min 20min 30min 40min</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>evolution of heart rate variability</measure>
    <time_frame>-20min 20min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hedonic food intake</measure>
    <time_frame>40min</time_frame>
    <description>amount of milkshake drunk</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>positive emotion and fatty acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>positive emotion induction combine with 2.g Dodecanoic acid intragastric infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neutral emotion and fatty acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>neutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>positive emotion and saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>positive emotion induction combine with saline intragastric infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neutral emotion and saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>neutral emotion induction combine with saline intragastric infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dodecanoic acid</intervention_name>
    <description>The middle chain saturated fatty acid that can be widely found in daily food.</description>
    <arm_group_label>neutral emotion and fatty acid</arm_group_label>
    <arm_group_label>positive emotion and fatty acid</arm_group_label>
    <other_name>Lauric acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive emotion</intervention_name>
    <description>Positive emotion induced by facial expressions and classic music.</description>
    <arm_group_label>positive emotion and fatty acid</arm_group_label>
    <arm_group_label>positive emotion and saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>saline</description>
    <arm_group_label>neutral emotion and saline</arm_group_label>
    <arm_group_label>positive emotion and saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>neutral emotion</intervention_name>
    <description>Neutral emotion induced by facial expressions and classic music.</description>
    <arm_group_label>neutral emotion and fatty acid</arm_group_label>
    <arm_group_label>neutral emotion and saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy women&#xD;
&#xD;
          -  age &gt; 18 and &lt; 60.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5% of body weight&#xD;
             in the past three months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic medical illness affecting the gastrointestinal, endocrine, cardiovascular or&#xD;
             nervous system (risk of) pregnancy history of upper gastrointestinal surgery history&#xD;
             of behavioral, therapeutic or surgical treatment aiming at or leading to weight&#xD;
             loss/gain psychiatric disorders, including (history of) depression or eating disorders&#xD;
             alcohol abuse or dependence regular use of medication, except for oral contraception&#xD;
             use of any drugs, including cannabis, during the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lukas Van Oudenhove, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <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>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>
  <reference>
    <citation>Parker BA, Sturm K, MacIntosh CG, Feinle C, Horowitz M, Chapman IM. Relation between food intake and visual analogue scale ratings of appetite and other sensations in healthy older and young subjects. Eur J Clin Nutr. 2004 Feb;58(2):212-8. doi: 10.1038/sj.ejcn.1601768.</citation>
    <PMID>14749739</PMID>
  </reference>
  <reference>
    <citation>Mayer EA. Gut feelings: the emerging biology of gut-brain communication. Nat Rev Neurosci. 2011 Jul 13;12(8):453-66. doi: 10.1038/nrn3071.</citation>
    <PMID>21750565</PMID>
  </reference>
  <reference>
    <citation>Mayer EA, Naliboff BD, Craig AD. Neuroimaging of the brain-gut axis: from basic understanding to treatment of functional GI disorders. Gastroenterology. 2006 Dec;131(6):1925-42. doi: 10.1053/j.gastro.2006.10.026. No abstract available.</citation>
    <PMID>17188960</PMID>
  </reference>
  <reference>
    <citation>Mitterschiffthaler MT, Fu CH, Dalton JA, Andrew CM, Williams SC. A functional MRI study of happy and sad affective states induced by classical music. Hum Brain Mapp. 2007 Nov;28(11):1150-62. doi: 10.1002/hbm.20337.</citation>
    <PMID>17290372</PMID>
  </reference>
  <reference>
    <citation>Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.</citation>
    <PMID>10702749</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to ethical rules the individual participant data will be kept confidential.</ipd_description>
  </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/NCT02982616
org study id: S55863
nct id: NCT02982616
lead sponsor: 
has dmc: No
The purpose of this study is to test whether intragastrically infused fatty acid will
      interact with positive emotion induction and if this effect is mediated by gut hormones.
This study aims at the possible effect of subliminal intragastric administration of fatty
      acids on responses to positive emotion induction, based on our earlier findings that
      subjective administration of fatty acid decreases neural responses to negative mood induction
      (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the
      participants sign the informed consent form, an intravenous catheter is placed in the
      forearm, and a naso-gastric tube inserted through the nose. Then the test subject is
      connected to the equipment in order to record the activity of the autonomic nervous system,
      via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid
      solution (Dodecanoic acid, "fatty acid" condition) or a physiological saline solution (
      "control" condition) intragastrically. The intragastric administration of low doses of this
      food ingredient has already been used in several previous studies by our research group and
      has proven perfectly safe. A positive or neutral emotional state will be induced by the
      combination of looking at emotional facial expressions and listening to classical music
      pieces that were previously validated for this purpose; This combination of incentives has
      already been used in previous studies of our research group. Responses will be measured by
      means of validated self-report scales and measurements of the vagal tone. We also take blood
      samples on a regular basis by the intravenous catheter for determination of gastrointestinal
      hormones, given our hypothesis that this may explain the effect on emotions. After removal of
      the nasogastric tube, the influence of subliminal administration of fatty acids and emotional
      state on food intake measured by means of a validated and previously drink test used in which
      participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means
      of classical music pieces continue. Finally, the intravenous catheter is removed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: time evolution of VAS from the beginning until the end of a study visit
time frame: -10min 0min 10min 20min 30min 40min
description: visual analogue scale for appetite related sensations
measure: time evolution of gut hormones from the beginning until the end of a study visit
time frame: -10min 10min 20min 30min 40min
measure: evolution of heart rate variability
time frame: -20min 20min
measure: hedonic food intake
time frame: 40min
description: amount of milkshake drunk
arm group label: positive emotion and fatty acid
arm group type: Experimental
description: positive emotion induction combine with 2.g Dodecanoic acid intragastric infusion
arm group label: neutral emotion and fatty acid
arm group type: Experimental
description: neutral emotion induction combine with 2.g Dodecanoic acid intragastric infusion
arm group label: positive emotion and saline
arm group type: Experimental
description: positive emotion induction combine with saline intragastric infusion
arm group label: neutral emotion and saline
arm group type: Placebo Comparator
description: neutral emotion induction combine with saline intragastric infusion
intervention type: Dietary Supplement
intervention name: Dodecanoic acid
description: The middle chain saturated fatty acid that can be widely found in daily food.
arm group label: neutral emotion and fatty acid
arm group label: positive emotion and fatty acid
other name: Lauric acid
intervention type: Behavioral
intervention name: Positive emotion
description: Positive emotion induced by facial expressions and classic music.
arm group label: positive emotion and fatty acid
arm group label: positive emotion and saline
intervention type: Dietary Supplement
intervention name: saline
description: saline
arm group label: neutral emotion and saline
arm group label: positive emotion and saline
intervention type: Behavioral
intervention name: neutral emotion
description: Neutral emotion induced by facial expressions and classic music.
arm group label: neutral emotion and fatty acid
arm group label: neutral emotion and saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lukas Van Oudenhove, Prof
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
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
citation: Parker BA, Sturm K, MacIntosh CG, Feinle C, Horowitz M, Chapman IM. Relation between food intake and visual analogue scale ratings of appetite and other sensations in healthy older and young subjects. Eur J Clin Nutr. 2004 Feb;58(2):212-8. doi: 10.1038/sj.ejcn.1601768.
PMID: 14749739
citation: Mayer EA. Gut feelings: the emerging biology of gut-brain communication. Nat Rev Neurosci. 2011 Jul 13;12(8):453-66. doi: 10.1038/nrn3071.
PMID: 21750565
citation: Mayer EA, Naliboff BD, Craig AD. Neuroimaging of the brain-gut axis: from basic understanding to treatment of functional GI disorders. Gastroenterology. 2006 Dec;131(6):1925-42. doi: 10.1053/j.gastro.2006.10.026. No abstract available.
PMID: 17188960
citation: Mitterschiffthaler MT, Fu CH, Dalton JA, Andrew CM, Williams SC. A functional MRI study of happy and sad affective states induced by classical music. Hum Brain Mapp. 2007 Nov;28(11):1150-62. doi: 10.1002/hbm.20337.
PMID: 17290372
citation: Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
PMID: 10702749
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Lukas Van Oudenhove
investigator title: Professor
sharing ipd: No
ipd description: Due to ethical rules the individual participant data will be kept confidential.