<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/NCT03758482</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)338/2016F</org_study_id>
    <nct_id>NCT03758482</nct_id>
  </id_info>
  <brief_title>Biological Response to Meal Ingestion: Gender Differences</brief_title>
  <official_title>Factors That Determine the Responses to Meal Ingestion: Effect of Gender on Sensory and Metabolomic Responses</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>
      Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard&#xD;
      probe meal. Participants (12 men and 12 women) will be instructed to eat a standard dinner&#xD;
      the day before, to consume a standard breakfast at home after overnight fast, and to report&#xD;
      to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will&#xD;
      be conducted in a quiet, isolated room with participants sitting on a chair. Participants&#xD;
      will ingest a standard probe meal (750 Kcal). Perception of homeostatic sensations&#xD;
      (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) will be&#xD;
      measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals&#xD;
      up to 60 min after the probe meal. Heart rate variability, blood pressure and body&#xD;
      temperature were measured before and after the meal. Blood samples for metabolomic analysis&#xD;
      were taken before and 30 min after the meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2018</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">September 28, 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>Fullness sensation induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Gender differences in fullness sensation [(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; between and within subject's factors: gender and time, respectively; covariate: premeal scores).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hunger/satiety induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Gender differences in 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; between and within subject's factors: gender and time, respectively; covariate: premeal scores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in digestive well-being induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Gender differences in 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; between and within subject's factors: gender and time, respectively; 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>Gender differences in mood [(measured by a 10 cm scale graded from -5 (negative) to +5 (postive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circulating metabolites induced by the probe meal</measure>
    <time_frame>1 day</time_frame>
    <description>Change in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Men</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Probe meal</intervention_name>
    <description>The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.</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>
    <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>
  <results_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>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meal ingestion</keyword>
  <keyword>metabolomic 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/NCT03758482
org study id: PR(AG)338/2016F
nct id: NCT03758482
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard
      probe meal. Participants (12 men and 12 women) 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 4 h after breakfast. Studies will
      be conducted in a quiet, isolated room with participants sitting on a chair. Participants
      will ingest a standard probe meal (750 Kcal). 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. Heart rate variability, blood pressure and body
      temperature were measured before and after the meal. Blood samples for metabolomic analysis
      were taken before and 30 min after the meal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Fullness sensation induced by the probe meal
time frame: 1 day
description: Gender differences in fullness sensation [(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; between and within subject's factors: gender and time, respectively; covariate: premeal scores).
measure: Change in hunger/satiety induced by the probe meal
time frame: 1 day
description: Gender differences in 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; between and within subject's factors: gender and time, respectively; covariate: premeal scores).
measure: Change in digestive well-being induced by the probe meal
time frame: 1 day
description: Gender differences in 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; between and within subject's factors: gender and time, respectively; covariate: premeal scores).
measure: Change in mood induced by the probe meal
time frame: 1 day
description: Gender differences in mood [(measured by a 10 cm scale graded from -5 (negative) to +5 (postive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).
measure: Change in circulating metabolites induced by the probe meal
time frame: 1 day
description: Change in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance.
arm group label: Men
arm group type: Other
description: The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.
arm group label: Women
arm group type: Other
description: The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.
intervention type: Other
intervention name: Probe meal
description: The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.
arm group label: Men
arm group label: Women
criteria: 
gender: All
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