<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/NCT02255812</url>
  </required_header>
  <id_info>
    <org_study_id>EKBB 289/12/2</org_study_id>
    <nct_id>NCT02255812</nct_id>
  </id_info>
  <brief_title>Taste Physiology in Healthy, Normal-weight Volunteers</brief_title>
  <official_title>Taste Physiology in Healthy, Normal-weight Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and&#xD;
      bitter. The receptors found on the tongue are also found in the entire gut. The correlation&#xD;
      of stimulation of these gut receptors and brain activity has not yet been examined. The&#xD;
      objectives are to investigate the effect of different taste substances on i) regional brain&#xD;
      activity and ii) satiation peptide release.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI)</measure>
    <time_frame>changes from baseline to one hour after treatment</time_frame>
    <description>Changes in resting state functional connectivity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>gastrointestinal satiation peptide secretion</measure>
    <time_frame>changes from baseline to one hour after treatment</time_frame>
    <description>Unit of Measure: glucagon like peptide-1 (GLP-1) in pg/mL, peptide tyrosine tyrosine (PYY) in pg/mL and gastric inhibitory polypeptide (GIP) in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glucose and insulin secretion</measure>
    <time_frame>changes from baseline to one hour after treatment</time_frame>
    <description>Unit of Measure: glucose in mmol/L, insulin in μU/mL</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Exploratory Behavior</condition>
  <arm_group>
    <arm_group_label>200 mL tap water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intragastric instillation of 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 g citric acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 g salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.017 g quinine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 g monosodium glutamate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25 g glucose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>200 mL tap water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>2 g citric acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>2 g salt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>0.017 g quinine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>1 g monosodium glutamate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube</intervention_name>
    <arm_group_label>25 g glucose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-handed healthy males&#xD;
&#xD;
          -  Body-mass index of &lt; 25&#xD;
&#xD;
          -  Age 18-45 years&#xD;
&#xD;
          -  no drugs&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Regular intake of medications (except for oral contraceptives)&#xD;
&#xD;
          -  Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia&#xD;
&#xD;
          -  History of gastrointestinal disorders&#xD;
&#xD;
          -  Food allergies, glutamate intolerance&#xD;
&#xD;
          -  Body piercings that cannot be removed&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Beglinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Basel</city>
        <zip>CH-4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quinine</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</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/NCT02255812
org study id: EKBB 289/12/2
nct id: NCT02255812
lead sponsor: 
has dmc: No
Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and
      bitter. The receptors found on the tongue are also found in the entire gut. The correlation
      of stimulation of these gut receptors and brain activity has not yet been examined. The
      objectives are to investigate the effect of different taste substances on i) regional brain
      activity and ii) satiation peptide release.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI)
time frame: changes from baseline to one hour after treatment
description: Changes in resting state functional connectivity
measure: gastrointestinal satiation peptide secretion
time frame: changes from baseline to one hour after treatment
description: Unit of Measure: glucagon like peptide-1 (GLP-1) in pg/mL, peptide tyrosine tyrosine (PYY) in pg/mL and gastric inhibitory polypeptide (GIP) in pg/mL
measure: glucose and insulin secretion
time frame: changes from baseline to one hour after treatment
description: Unit of Measure: glucose in mmol/L, insulin in μU/mL
arm group label: 200 mL tap water
arm group type: Placebo Comparator
description: Single intragastric instillation of 200 mL tap water via nasogastric tube
arm group label: 2 g citric acid
arm group type: Active Comparator
description: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube
arm group label: 2 g salt
arm group type: Active Comparator
description: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
arm group label: 0.017 g quinine
arm group type: Active Comparator
description: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube
arm group label: 1 g monosodium glutamate
arm group type: Active Comparator
description: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
arm group label: 25 g glucose
arm group type: Active Comparator
description: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 200 mL tap water via nasogastric tube
arm group label: 200 mL tap water
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube
arm group label: 2 g citric acid
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
arm group label: 2 g salt
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube
arm group label: 0.017 g quinine
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
arm group label: 1 g monosodium glutamate
intervention type: Dietary Supplement
intervention name: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube
arm group label: 25 g glucose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph Beglinger, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Quinine
mesh term: Citric Acid
mesh term: Sodium Citrate