<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/NCT03773432</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)338/2016G</org_study_id>
    <nct_id>NCT03773432</nct_id>
  </id_info>
  <brief_title>Influence of Meal Schedule: Gender Differences</brief_title>
  <official_title>Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences</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>
      Gender differences in the effect of meal schedule will be studied in a parallel design (10&#xD;
      women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL&#xD;
      water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in&#xD;
      the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as&#xD;
      the differences between the responses on both study days. Participants will be instructed to&#xD;
      eat standard dinner the day before and to consume standard breakfast at home the day of the&#xD;
      afternoon test. Studies will be conducted in a quiet, isolated room with participants siting&#xD;
      on a chair. Perception 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">August 13, 2018</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in digestive well-being induced by meal schedule</measure>
    <time_frame>1 day</time_frame>
    <description>Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to afternoon and morning meals by repeated measures ANCOVA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fullness sensation induced by meal schedule</measure>
    <time_frame>1 day</time_frame>
    <description>Change in digestive well-being measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to afternoon and morning meals by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood induced by meal schedule</measure>
    <time_frame>1 day</time_frame>
    <description>Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to afternoon and morning meals by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hunger/satiety induced by meal schedule</measure>
    <time_frame>1 day</time_frame>
    <description>Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to afternoon and morning meals by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Men</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Probe meal</intervention_name>
    <description>The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).</description>
    <arm_group_label>Men</arm_group_label>
    <arm_group_label>Women</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>All</gender>
    <gender_based>Yes</gender_based>
    <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>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meal ingestion</keyword>
  <keyword>meal schedule</keyword>
  <keyword>postprandial responses</keyword>
  <keyword>hedonic sensations</keyword>
  <keyword>homeostatic sensations</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/NCT03773432
org study id: PR(AG)338/2016G
nct id: NCT03773432
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gender differences in the effect of meal schedule will be studied in a parallel design (10
      women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL
      water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in
      the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as
      the differences between the responses on both study days. Participants will be instructed to
      eat standard dinner the day before and to consume standard breakfast at home the day of the
      afternoon test. Studies will be conducted in a quiet, isolated room with participants siting
      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: None (Open Label)
measure: Change in digestive well-being induced by meal schedule
time frame: 1 day
description: Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to afternoon and morning meals by repeated measures ANCOVA.
measure: Change in fullness sensation induced by meal schedule
time frame: 1 day
description: Change in digestive well-being measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to afternoon and morning meals by repeated measures ANCOVA.
measure: Change in mood induced by meal schedule
time frame: 1 day
description: Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to afternoon and morning meals by repeated measures ANCOVA.
measure: Change in hunger/satiety induced by meal schedule
time frame: 1 day
description: Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to afternoon and morning meals by repeated measures ANCOVA.
arm group label: Men
arm group type: Other
description: In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.
arm group label: Women
arm group type: Other
description: In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.
intervention type: Other
intervention name: Probe meal
description: The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).
arm group label: Men
arm group label: Women
criteria: 
gender: All
gender based: Yes
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