<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/NCT02997917</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)338/2016A</org_study_id>
    <nct_id>NCT02997917</nct_id>
  </id_info>
  <brief_title>Effect of Education on the Responses to Meal Ingestion</brief_title>
  <official_title>Factors That Determine the Response to Meal Ingested: Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low&#xD;
      temperature and 25 g bread) will be studied in a parallel design. The effects of education&#xD;
      will be tested in two different groups in random order: real versus sham education. In each&#xD;
      group the responses to a probe meal will be tested on 2 different days before and after the&#xD;
      intervention. Participants will be instructed to eat a standard dinner the day before, to&#xD;
      consume a standard breakfast at home after overnight fast, and to report to the laboratory,&#xD;
      where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a&#xD;
      quiet, isolated room with participants sitting on a chair. Perception will be measured at 5&#xD;
      min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min&#xD;
      after the probe meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in digestive well-being measured after a test meal by the end of the intervention versus before.</measure>
    <time_frame>1 day</time_frame>
    <description>Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in satiety measured after a test meal by the end of the intervention versus before</measure>
    <time_frame>1 day</time_frame>
    <description>Change in average satiety measured by 0-10 score scales at the end of the test meal administered before and after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fullness sensation measured after a test meal by the end of the intervention versus before.</measure>
    <time_frame>1 day</time_frame>
    <description>Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in discomfort/pain measured after a test meal by the end of the intervention versus before</measure>
    <time_frame>1 day</time_frame>
    <description>Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham</intervention_name>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - non-obese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of gastrointestinal symptoms&#xD;
&#xD;
          -  prior obesity&#xD;
&#xD;
          -  use of medications&#xD;
&#xD;
          -  history of anosmia and ageusia&#xD;
&#xD;
          -  current dieting&#xD;
&#xD;
          -  alcohol abuse&#xD;
&#xD;
          -  psychological disorders&#xD;
&#xD;
          -  eating disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Azpiroz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fernando Azpiroz</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02997917
org study id: PR(AG)338/2016A
nct id: NCT02997917
lead sponsor: 
has dmc: No
The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low
      temperature and 25 g bread) will be studied in a parallel design. The effects of education
      will be tested in two different groups in random order: real versus sham education. In each
      group the responses to a probe meal will be tested on 2 different days before and after the
      intervention. Participants will be instructed to eat a standard dinner the day before, to
      consume a standard breakfast at home after overnight fast, and to report to the laboratory,
      where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a
      quiet, isolated room with participants sitting on a chair. Perception will be measured at 5
      min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min
      after the probe meal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in digestive well-being measured after a test meal by the end of the intervention versus before.
time frame: 1 day
description: Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention.
measure: Change in satiety measured after a test meal by the end of the intervention versus before
time frame: 1 day
description: Change in average satiety measured by 0-10 score scales at the end of the test meal administered before and after intervention.
measure: Change in fullness sensation measured after a test meal by the end of the intervention versus before.
time frame: 1 day
description: Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.
measure: Change in discomfort/pain measured after a test meal by the end of the intervention versus before
time frame: 1 day
description: Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.
arm group label: Education
arm group type: Experimental
description: Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors).
arm group label: Sham
arm group type: Sham Comparator
description: Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided.
intervention type: Behavioral
intervention name: Education
arm group label: Education
intervention type: Behavioral
intervention name: Sham
arm group label: Sham
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Azpiroz, MD
role: Principal Investigator
affiliation: University Hospital Vall d'Hebron
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: No