<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/NCT03783221</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)338/2016J</org_study_id>
    <nct_id>NCT03783221</nct_id>
  </id_info>
  <brief_title>Effect of Previous Diet</brief_title>
  <official_title>Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet</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 digestive responses associated to homeostatic and hedonic sensations.&#xD;
      The responses to meal ingestion are modulated by conditioning factors. Single-centre,&#xD;
      cross-over, random, open label study comparing the effect of a high-fat/low-residue diet&#xD;
      versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects&#xD;
      each diet will be administered during 2 weeks in random order; each diet will be preceded by&#xD;
      2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet&#xD;
      on the responses to comfort and flatulogenic meals, intestinal gas production and digestive&#xD;
      sensations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Actual">April 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 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 comfort meal</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 comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fullness sensation induced by comfort meal</measure>
    <time_frame>1 day</time_frame>
    <description>Change in fullness sensation measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood induced by comfort meal</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 comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hunger/satiety induced by comfort meal</measure>
    <time_frame>1 day</time_frame>
    <description>Change in hunger/satiety measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiated) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal gas evacuation in response to a flatulogenic meal.</measure>
    <time_frame>1 day</time_frame>
    <description>Volume of intestinal gas evacuation per anus measured during 4 hours after ingestion of a flatulogenic meal during high-fat versus high-residue diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal gas production</measure>
    <time_frame>2 days</time_frame>
    <description>Number of daytime anal gas evacuations measured by an event marker. Participants will be instructed to carry the event marker during daytime and to register every passage of gas per anus for the last two days during high-fat versus high-residue diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensation of flatulence</measure>
    <time_frame>2 days</time_frame>
    <description>Sensation of flatulence measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) for the last two days during high-fat versus high-residue diet.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>High-fat diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High-residue diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-fat diet</intervention_name>
    <description>The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..</description>
    <arm_group_label>High-fat diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-residue diet</intervention_name>
    <description>The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.</description>
    <arm_group_label>High-residue diet</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>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meal ingestion</keyword>
  <keyword>diet</keyword>
  <keyword>postprandial responses</keyword>
  <keyword>hedonic sensations</keyword>
  <keyword>homeostatic sensations</keyword>
  <keyword>intestinal gas production</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/NCT03783221
org study id: PR(AG)338/2016J
nct id: NCT03783221
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations.
      The responses to meal ingestion are modulated by conditioning factors. Single-centre,
      cross-over, random, open label study comparing the effect of a high-fat/low-residue diet
      versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects
      each diet will be administered during 2 weeks in random order; each diet will be preceded by
      2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet
      on the responses to comfort and flatulogenic meals, intestinal gas production and digestive
      sensations.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in digestive well-being induced by comfort meal
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 comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
measure: Change in fullness sensation induced by comfort meal
time frame: 1 day
description: Change in fullness sensation measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
measure: Change in mood induced by comfort meal
time frame: 1 day
description: Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
measure: Change in hunger/satiety induced by comfort meal
time frame: 1 day
description: Change in hunger/satiety measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiated) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
measure: Intestinal gas evacuation in response to a flatulogenic meal.
time frame: 1 day
description: Volume of intestinal gas evacuation per anus measured during 4 hours after ingestion of a flatulogenic meal during high-fat versus high-residue diet.
measure: Intestinal gas production
time frame: 2 days
description: Number of daytime anal gas evacuations measured by an event marker. Participants will be instructed to carry the event marker during daytime and to register every passage of gas per anus for the last two days during high-fat versus high-residue diet.
measure: Sensation of flatulence
time frame: 2 days
description: Sensation of flatulence measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) for the last two days during high-fat versus high-residue diet.
arm group label: High-fat diet
arm group type: Experimental
arm group label: High-residue diet
arm group type: Active Comparator
intervention type: Other
intervention name: High-fat diet
description: The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..
arm group label: High-fat diet
intervention type: Other
intervention name: High-residue diet
description: The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.
arm group label: High-residue diet
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