<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/NCT01690182</url>
  </required_header>
  <id_info>
    <org_study_id>F/11/2010</org_study_id>
    <nct_id>NCT01690182</nct_id>
  </id_info>
  <brief_title>MRI Study of Stomach Volumes and Satiety</brief_title>
  <official_title>Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The GI MRI Research group at the University of Nottingham has been developing new,&#xD;
      non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.&#xD;
      In collaboration with food manufacturer Unilever, the investigators want to image the abdomen&#xD;
      of healthy volunteers after consumption of test meals of varying volume and energy density to&#xD;
      determine levels of gastric distension and investigate possible correlations of this with the&#xD;
      subjects' sense of satiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The tone of the proximal stomach decreases on meal intake through a process of gastric&#xD;
      accommodation, aimed at increasing the capacity of the stomach. An increased gastric volume&#xD;
      progressively distends the stomach, and this distension has been shown to have an inverse&#xD;
      relationship on appetite. The link is assumed to be based on activation of mechanoreceptors&#xD;
      lying in the walls of the stomach. On activation, vagal discharges are triggered, leading to&#xD;
      activation of hypothalamic neurons and regulation of feelings of satiety. Gasrtric emptying&#xD;
      is also regulated by duodenal feedback mechanisms triggered by the arrival and amount of&#xD;
      nutrients.&#xD;
&#xD;
      Based on current knowledge, a high volume test meal would be expected to produce more gastric&#xD;
      distension and satiety over a low volume test meal, and a low energy density food would be&#xD;
      expected to empty from the stomach faster than a high energy density food. Going on this&#xD;
      premise, study test meal 2 would be expected to empty faster than study test meal 1. These&#xD;
      phenomena will be investigated using non invasive Magnetic Resonance Imaging (MRI) methods.&#xD;
      MRI can measure gastric volumes serially and non-invasively with high spatial resolution.&#xD;
      Ultimately, the findings from this study will provide novel insights on mechanisms of gastric&#xD;
      distension and satiety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total gastric content half emptying time T50</measure>
    <time_frame>0 - 240 mins</time_frame>
    <description>Total gastric volume at half the experimental time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volumes of test meal in the stomach</measure>
    <time_frame>0 - 240 mins</time_frame>
    <description>gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relationship of gastric behaviour of test meal stomach volumes with satiety</measure>
    <time_frame>0 - 240 minutes</time_frame>
    <description>A comparison of the gastric volumes with satiety scores obtained throughout the experiment</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Study test meal 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study test meal 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High volume, low energy density test meal. Volunteers will be given 490 mL of a high volume low energy density test meal once in the morning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study test meal 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study test meal 1</intervention_name>
    <description>Volunteers will be fed with a high volume, high energy density test meal.</description>
    <arm_group_label>Study test meal 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study test meal 2</intervention_name>
    <description>Volunteers will be fed with a high volume, low energy density test meal</description>
    <arm_group_label>Study test meal 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study test meal 3</intervention_name>
    <description>Volunteers will be fed with a low volume, high energy density test meal</description>
    <arm_group_label>Study test meal 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Apparently healthy; no medical conditions that might affect the study measurements (as&#xD;
             determined by the study physician)&#xD;
&#xD;
          -  No use of medication that would interfere with the study measurements (as determined&#xD;
             by the study physician)&#xD;
&#xD;
          -  No use of antibiotics in the 3 months before the study or during the study&#xD;
&#xD;
          -  No reported participation in another nutritional or biomedical trial 3 months before&#xD;
             the study or during the study&#xD;
&#xD;
          -  Being used to eating 3 meals daily&#xD;
&#xD;
          -  BMI: 20 - 35 kg m-2&#xD;
&#xD;
          -  No reported participation in night shift work 2 weeks prior to the study or during the&#xD;
             study&#xD;
&#xD;
          -  Not taking part in strenuous exercise ≤10 hours/week&#xD;
&#xD;
          -  Not consuming more than 21 alcoholic test meals in a typical week&#xD;
&#xD;
          -  Not presently a smoker&#xD;
&#xD;
          -  No reported weight loss or gain of more than 10 % of bodyweight for 6 months before&#xD;
             the study&#xD;
&#xD;
          -  No eating disorder&#xD;
&#xD;
          -  No MRI contraindications; i.e absence of metal implants, infusion pumps and&#xD;
             pacemakers, as assessed by a MRI safety screening questionnaire&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  High or very high restrained eater&#xD;
&#xD;
          -  Use of any medically- or self-prescribed diet for the duration of the study&#xD;
&#xD;
          -  Allergies or food intolerances&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luca Marciani, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unilever Research and Development</name>
      <address>
        <city>Olivier van Noortlann 120</city>
        <state>AT Vlaardingen</state>
        <zip>3133</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre</name>
      <address>
        <city>University of Nottingham</city>
        <state>Nottingham</state>
        <zip>NG7 2RD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 17, 2012</last_update_submitted>
  <last_update_submitted_qc>December 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal physiology</keyword>
  <keyword>MRI</keyword>
  <keyword>gastric volumes</keyword>
  <keyword>satiety</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/NCT01690182
org study id: F/11/2010
nct id: NCT01690182
lead sponsor: 
collaborator: 
has dmc: No
The GI MRI Research group at the University of Nottingham has been developing new,
      non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.
      In collaboration with food manufacturer Unilever, the investigators want to image the abdomen
      of healthy volunteers after consumption of test meals of varying volume and energy density to
      determine levels of gastric distension and investigate possible correlations of this with the
      subjects' sense of satiety.
The tone of the proximal stomach decreases on meal intake through a process of gastric
      accommodation, aimed at increasing the capacity of the stomach. An increased gastric volume
      progressively distends the stomach, and this distension has been shown to have an inverse
      relationship on appetite. The link is assumed to be based on activation of mechanoreceptors
      lying in the walls of the stomach. On activation, vagal discharges are triggered, leading to
      activation of hypothalamic neurons and regulation of feelings of satiety. Gasrtric emptying
      is also regulated by duodenal feedback mechanisms triggered by the arrival and amount of
      nutrients.

      Based on current knowledge, a high volume test meal would be expected to produce more gastric
      distension and satiety over a low volume test meal, and a low energy density food would be
      expected to empty from the stomach faster than a high energy density food. Going on this
      premise, study test meal 2 would be expected to empty faster than study test meal 1. These
      phenomena will be investigated using non invasive Magnetic Resonance Imaging (MRI) methods.
      MRI can measure gastric volumes serially and non-invasively with high spatial resolution.
      Ultimately, the findings from this study will provide novel insights on mechanisms of gastric
      distension and satiety.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Total gastric content half emptying time T50
time frame: 0 - 240 mins
description: Total gastric volume at half the experimental time
measure: Volumes of test meal in the stomach
time frame: 0 - 240 mins
description: gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time
measure: Relationship of gastric behaviour of test meal stomach volumes with satiety
time frame: 0 - 240 minutes
description: A comparison of the gastric volumes with satiety scores obtained throughout the experiment
arm group label: Study test meal 1
arm group type: Experimental
description: High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning
arm group label: Study test meal 2
arm group type: Experimental
description: High volume, low energy density test meal. Volunteers will be given 490 mL of a high volume low energy density test meal once in the morning
arm group label: Study test meal 3
arm group type: Experimental
description: A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning.
intervention type: Dietary Supplement
intervention name: Study test meal 1
description: Volunteers will be fed with a high volume, high energy density test meal.
arm group label: Study test meal 1
intervention type: Dietary Supplement
intervention name: Study test meal 2
description: Volunteers will be fed with a high volume, low energy density test meal
arm group label: Study test meal 2
intervention type: Dietary Supplement
intervention name: Study test meal 3
description: Volunteers will be fed with a low volume, high energy density test meal
arm group label: Study test meal 3
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luca Marciani, PhD
role: Principal Investigator
affiliation: University of Nottingham
facility: 
facility: 
country: Netherlands
country: United Kingdom
responsible party type: Sponsor