<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/NCT02213406</url>
  </required_header>
  <id_info>
    <org_study_id>NSFP</org_study_id>
    <nct_id>NCT02213406</nct_id>
  </id_info>
  <brief_title>Neuronal and Sensory Perception of Fat</brief_title>
  <official_title>Fat and the Brain-Neuronal and Sensory Fat Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will examine neuronal and sensory fat perception. Our hypothesis is that&#xD;
      subjects being either hypersensitive or hyposensitive for fat will show different brain&#xD;
      activities. Therefore the investigators will conduct functional magnetic resonance imaging&#xD;
      (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Fat detection thresholds</measure>
    <time_frame>each measurement day</time_frame>
    <description>A sensory test will be conducted to establish individual fat detection thresholds. It is expected that subjects* brain activity is dependent on sensory fat sensitivity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain activity</measure>
    <time_frame>pre and post meal intake</time_frame>
    <description>We are interested in brain activations following the consumption of yogurt with either a high or a low fat concentration. To assess this, before as well as after fat intake brain activity will be measured using functional magnetic resonance imaging (fMRI). We expect that brain activity will differ between the high and the low fat yogurt condition.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Fat Perception in the Brain</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fat detection threshold test, intake of high and low fat yogurt, fMRI-measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>yogurt</intervention_name>
    <description>Subjects will receive yogurt with varying fat concentrations</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lactose intolerance&#xD;
&#xD;
          -  fMRI contraindications (metal implants,...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Clinic of Tuebingen, fMEG Center</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>July 4, 2017</last_update_submitted>
  <last_update_submitted_qc>July 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Sabine Frank</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02213406
org study id: NSFP
nct id: NCT02213406
lead sponsor: 
has dmc: No
This project will examine neuronal and sensory fat perception. Our hypothesis is that
      subjects being either hypersensitive or hyposensitive for fat will show different brain
      activities. Therefore the investigators will conduct functional magnetic resonance imaging
      (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
measure: Fat detection thresholds
time frame: each measurement day
description: A sensory test will be conducted to establish individual fat detection thresholds. It is expected that subjects* brain activity is dependent on sensory fat sensitivity.
measure: Brain activity
time frame: pre and post meal intake
description: We are interested in brain activations following the consumption of yogurt with either a high or a low fat concentration. To assess this, before as well as after fat intake brain activity will be measured using functional magnetic resonance imaging (fMRI). We expect that brain activity will differ between the high and the low fat yogurt condition.
arm group label: intervention group
arm group type: Experimental
description: Fat detection threshold test, intake of high and low fat yogurt, fMRI-measurements
intervention type: Dietary Supplement
intervention name: yogurt
description: Subjects will receive yogurt with varying fat concentrations
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Sabine Frank
investigator title: Dr.