<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/NCT02217605</url>
  </required_header>
  <id_info>
    <org_study_id>A32006_FRU</org_study_id>
    <nct_id>NCT02217605</nct_id>
  </id_info>
  <brief_title>31P Magnetic Resonance Spectroscopy Fructose Study</brief_title>
  <acronym>31PMRS_FRU</acronym>
  <official_title>Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephen Bawden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotechnology and Biological Sciences Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of an oral fructose challenge on liver&#xD;
      adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a&#xD;
      potential measure measure of liver health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses 31P spectra acquired from the liver in healthy subjects following a fructose&#xD;
      drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver&#xD;
      lipid levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatic ATP reserves following an oral fructose challenge</measure>
    <time_frame>2 hours post prandial</time_frame>
    <description>Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen</measure>
    <time_frame>2 hours post prandial</time_frame>
    <description>Measure baseline liver lipid and glycogen using magnetic resonance spectroscopy and correlate BMI, lipid and glycogen levels with rate of ATP depletion and recovery following an oral fructose challenge</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fructose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fructose</intervention_name>
    <description>Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast</description>
    <arm_group_label>Fructose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age 18 - 30&#xD;
&#xD;
          -  BMI 20 - 27 kg/m^2&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Liver disease or Metabolic Disorders&#xD;
&#xD;
          -  Metal implants (not suitable for MRI)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luca Marciani</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2RD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Nottingham</investigator_affiliation>
    <investigator_full_name>Stephen Bawden</investigator_full_name>
    <investigator_title>CASE studentship researcher</investigator_title>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>Oral Fructose Challenge</keyword>
  <keyword>31P MRS</keyword>
  <keyword>Liver</keyword>
  <keyword>Subjects</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/NCT02217605
org study id: A32006_FRU
nct id: NCT02217605
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the effects of an oral fructose challenge on liver
      adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a
      potential measure measure of liver health.
This study uses 31P spectra acquired from the liver in healthy subjects following a fructose
      drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver
      lipid levels
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Hepatic ATP reserves following an oral fructose challenge
time frame: 2 hours post prandial
description: Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy
measure: Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen
time frame: 2 hours post prandial
description: Measure baseline liver lipid and glycogen using magnetic resonance spectroscopy and correlate BMI, lipid and glycogen levels with rate of ATP depletion and recovery following an oral fructose challenge
arm group label: Fructose
arm group type: Experimental
description: Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS
intervention type: Dietary Supplement
intervention name: Fructose
description: Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast
arm group label: Fructose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luca Marciani
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: University of Nottingham
investigator full name: Stephen Bawden
investigator title: CASE studentship researcher