<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/NCT03827707</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)338/2016H</org_study_id>
    <nct_id>NCT03827707</nct_id>
  </id_info>
  <brief_title>Effect of Ambient Noise on the Responses to Meal Ingestion</brief_title>
  <official_title>Factors That Determine the Responses to Meal Ingestion: Effect of Ambient Noise</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meal ingestion induces sensations that are influenced by a series of conditioning factors.&#xD;
      Aim: to determine the effect of ambient noise on the sensory responses to a standard probe&#xD;
      meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise&#xD;
      versus silence on the sensations induced by a probe meal. Participants (12 men) will be&#xD;
      instructed to eat a standard dinner the day before, to consume a standard breakfast at home&#xD;
      after overnight fast, and to report to the laboratory, where the test meal will be&#xD;
      administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with&#xD;
      participants sitting on a chair. One study day, a noise will applied via headphones for 60&#xD;
      min after meal ingestion and the other day headphones without sound will applied. Perception&#xD;
      of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive&#xD;
      well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after&#xD;
      ingestion and at 10 min intervals up to 60 min after the probe meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2018</start_date>
  <completion_date type="Actual">February 22, 2019</completion_date>
  <primary_completion_date type="Actual">February 8, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in digestive well-being induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Effect of noise on digestive well-being [measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fullness sensation induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Effect of noise on fullness [measured by a 10 cm scale graded from 0 (not at all) to 10 (very much)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Effect of noise on mood [measured by a 10 cm scale graded from -5 (negative) to +5 (positive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hunger/satiety induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Effect of noise on hunger/satiety [measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Noise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Silence</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Noise</intervention_name>
    <description>Noise applied via headphones during 60 min after meal ingestion</description>
    <arm_group_label>Noise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Silence</intervention_name>
    <description>Headphones without sound applied during 60 min after meal ingestion</description>
    <arm_group_label>Silence</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>
  <location>
    <facility>
      <name>University Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.</citation>
    <PMID>29392797</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meal ingestion</keyword>
  <keyword>postprandial responses</keyword>
  <keyword>hedonic sensations</keyword>
  <keyword>homeostatic sensations</keyword>
  <keyword>ambient noise</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/NCT03827707
org study id: PR(AG)338/2016H
nct id: NCT03827707
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Meal ingestion induces sensations that are influenced by a series of conditioning factors.
      Aim: to determine the effect of ambient noise on the sensory responses to a standard probe
      meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise
      versus silence on the sensations induced by a probe meal. Participants (12 men) 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 test meal will be
      administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with
      participants sitting on a chair. One study day, a noise will applied via headphones for 60
      min after meal ingestion and the other day headphones without sound will applied. Perception
      of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive
      well-being, mood) 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: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in digestive well-being induced by the probe meal
time frame: 1 day
description: Effect of noise on digestive well-being [measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).
measure: Change in fullness sensation induced by the probe meal
time frame: 1 day
description: Effect of noise on fullness [measured by a 10 cm scale graded from 0 (not at all) to 10 (very much)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).
measure: Change in mood induced by the probe meal
time frame: 1 day
description: Effect of noise on mood [measured by a 10 cm scale graded from -5 (negative) to +5 (positive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).
measure: Change in hunger/satiety induced by the probe meal
time frame: 1 day
description: Effect of noise on hunger/satiety [measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).
arm group label: Noise
arm group type: Experimental
arm group label: Silence
arm group type: Sham Comparator
intervention type: Behavioral
intervention name: Noise
description: Noise applied via headphones during 60 min after meal ingestion
arm group label: Noise
intervention type: Behavioral
intervention name: Silence
description: Headphones without sound applied during 60 min after meal ingestion
arm group label: Silence
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
PMID: 29392797
responsible party type: Sponsor