<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/NCT03247114</url>
  </required_header>
  <id_info>
    <org_study_id>1930</org_study_id>
    <nct_id>NCT03247114</nct_id>
  </id_info>
  <brief_title>fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose</brief_title>
  <official_title>Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unilever R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will consist of five occasions with one week in between. BOLD signal intensity of&#xD;
      the hypothalamus will be measured using fMRI. Measurements will be done before and after&#xD;
      drinking 300 ml plain water (reference) or water to which different sweeteners will be added.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothalamus is known to be important for control of feeding behaviour as well as the&#xD;
      regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive&#xD;
      method, which detects transient haemodynamic changes in the brain, using blood oxygen level&#xD;
      dependent (BOLD) signal differences.&#xD;
&#xD;
      In order to investigate the role of hypothalamic neural activity in response to different&#xD;
      sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water&#xD;
      or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose&#xD;
      (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.&#xD;
&#xD;
      The study uses a randomized cross-over design in 16 healthy male subjects with a normal body&#xD;
      weight. There will be an interval of at least one week between the five occasions.&#xD;
&#xD;
      Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously&#xD;
      measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after&#xD;
      drinking).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2015</start_date>
  <completion_date type="Actual">May 22, 2015</completion_date>
  <primary_completion_date type="Actual">May 22, 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypothalamic function in response to glucose, fructose, sucrose, and sucralose</measure>
    <time_frame>Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.</time_frame>
    <description>fMRI will be performed before and after ingestion</description>
  </primary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First plain water, then glucose, then sucralose, then fructose and then sucrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First plain water, then sucralose, then glucose, then sucrose and then fructose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First glucose, then plain water, then fructose, then sucralose and then sucrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First glucose, then fructose, then plain water, then sucrose and then sucralose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First fructose, then glucose, then sucrose, then plain water and then sucralose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First fructose, then sucrose, then glucose, then sucralose and then plain water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First sucrose, then fructose, then sucralose, then glucose and then plain water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First sucrose, then sucralose, then fructose, then plain water and then glucose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First sucralose, then plain water, then sucrose, then glucose and then fructose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First sucralose, then sucrose, then plain water, then fructose and then glucose</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Water, 300 ml at room temperature</description>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucose</intervention_name>
    <description>Glucose, 50 grams in 300 ml water at room temperature</description>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fructose</intervention_name>
    <description>Fructose, 50 grams in 300 ml water at room temperature</description>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sucrose</intervention_name>
    <description>Sucrose, 50 grams in 300 ml water at room temperature</description>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sucralose</intervention_name>
    <description>Sucralose, 0.33 grams in 300 ml water at room temperature</description>
    <arm_group_label>Fructose-glucose-sucrose-water-sucralose</arm_group_label>
    <arm_group_label>Fructose-sucrose-glucose-sucralose-water</arm_group_label>
    <arm_group_label>Glucose-fructose-water-sucrose-sucralose</arm_group_label>
    <arm_group_label>Glucose-water-fructose-sucralose-sucrose</arm_group_label>
    <arm_group_label>Sucralose-sucrose-water-fructose-glucose</arm_group_label>
    <arm_group_label>Sucralose-water-sucrose-glucose-fructose</arm_group_label>
    <arm_group_label>Sucrose-fructose-sucralose-glucose-water</arm_group_label>
    <arm_group_label>Sucrose-sucralose-fructose-water-glucose</arm_group_label>
    <arm_group_label>Water-glucose-sucralose-fructose-sucrose</arm_group_label>
    <arm_group_label>water-sucralose-glucose-sucrose-fructose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Age between 18 and 25 years&#xD;
&#xD;
          -  BMI between 20 and 24 kg/m2&#xD;
&#xD;
          -  Length between 170 and 190 centimetres&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose&#xD;
             tolerance, hypoglycaemia).&#xD;
&#xD;
          -  Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression)&#xD;
             affecting brain&#xD;
&#xD;
          -  Any significant chronic disease&#xD;
&#xD;
          -  Renal or hepatic disease&#xD;
&#xD;
          -  Recent weight changes or attempts to lose weight (&gt; 3 kg weight gain or loss, within&#xD;
             the last 3 months)&#xD;
&#xD;
          -  Smoking (current or last 6 months)&#xD;
&#xD;
          -  Alcohol consumption of more than 21 units per week or use of recreational drugs at&#xD;
             present or in the last year&#xD;
&#xD;
          -  Recent blood donation (within the last 2 months)&#xD;
&#xD;
          -  Recent participation in other biomedical research projects (within the last 3 months),&#xD;
             participation in 3 or more biomedical research projects in one year&#xD;
&#xD;
          -  Contra-indication to MRI scanning:&#xD;
&#xD;
               -  Claustrophobia&#xD;
&#xD;
               -  Pacemakers and defibrillators&#xD;
&#xD;
               -  Nerve stimulators&#xD;
&#xD;
               -  Intracranial clips&#xD;
&#xD;
               -  Intraorbital or intraocular metallic fragments&#xD;
&#xD;
               -  Cochlear implants&#xD;
&#xD;
               -  Ferromagnetic implants&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeroen van der Grond, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03247114
org study id: 1930
nct id: NCT03247114
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will consist of five occasions with one week in between. BOLD signal intensity of
      the hypothalamus will be measured using fMRI. Measurements will be done before and after
      drinking 300 ml plain water (reference) or water to which different sweeteners will be added.
The hypothalamus is known to be important for control of feeding behaviour as well as the
      regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive
      method, which detects transient haemodynamic changes in the brain, using blood oxygen level
      dependent (BOLD) signal differences.

      In order to investigate the role of hypothalamic neural activity in response to different
      sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water
      or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose
      (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

      The study uses a randomized cross-over design in 16 healthy male subjects with a normal body
      weight. There will be an interval of at least one week between the five occasions.

      Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously
      measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after
      drinking).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Hypothalamic function in response to glucose, fructose, sucrose, and sucralose
time frame: Change from baseline (measured during 5 minutes before start of dinking) to post consumption (measured during 12 minutes after drinking). Drinking took 4 minutes.
description: fMRI will be performed before and after ingestion
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group type: Experimental
description: First plain water, then glucose, then sucralose, then fructose and then sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
arm group type: Experimental
description: First plain water, then sucralose, then glucose, then sucrose and then fructose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group type: Experimental
description: First glucose, then plain water, then fructose, then sucralose and then sucrose
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group type: Experimental
description: First glucose, then fructose, then plain water, then sucrose and then sucralose
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group type: Experimental
description: First fructose, then glucose, then sucrose, then plain water and then sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group type: Experimental
description: First fructose, then sucrose, then glucose, then sucralose and then plain water
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group type: Experimental
description: First sucrose, then fructose, then sucralose, then glucose and then plain water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group type: Experimental
description: First sucrose, then sucralose, then fructose, then plain water and then glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group type: Experimental
description: First sucralose, then plain water, then sucrose, then glucose and then fructose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group type: Experimental
description: First sucralose, then sucrose, then plain water, then fructose and then glucose
intervention type: Other
intervention name: Water
description: Water, 300 ml at room temperature
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
intervention type: Other
intervention name: Glucose
description: Glucose, 50 grams in 300 ml water at room temperature
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
intervention type: Other
intervention name: Fructose
description: Fructose, 50 grams in 300 ml water at room temperature
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
intervention type: Other
intervention name: Sucrose
description: Sucrose, 50 grams in 300 ml water at room temperature
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
intervention type: Other
intervention name: Sucralose
description: Sucralose, 0.33 grams in 300 ml water at room temperature
arm group label: Fructose-glucose-sucrose-water-sucralose
arm group label: Fructose-sucrose-glucose-sucralose-water
arm group label: Glucose-fructose-water-sucrose-sucralose
arm group label: Glucose-water-fructose-sucralose-sucrose
arm group label: Sucralose-sucrose-water-fructose-glucose
arm group label: Sucralose-water-sucrose-glucose-fructose
arm group label: Sucrose-fructose-sucralose-glucose-water
arm group label: Sucrose-sucralose-fructose-water-glucose
arm group label: Water-glucose-sucralose-fructose-sucrose
arm group label: water-sucralose-glucose-sucrose-fructose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeroen van der Grond, Dr
role: Principal Investigator
affiliation: Leiden University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No