<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/NCT03278249</url>
  </required_header>
  <id_info>
    <org_study_id>UCCI-BRAIN-16-01</org_study_id>
    <nct_id>NCT03278249</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma</brief_title>
  <official_title>Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</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 purpose of this research study is to see if people can produce ketones in their blood&#xD;
      with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your&#xD;
      blood by restricting carbohydrates to &lt;20 grams per day. Ketones are substances that are&#xD;
      produced in the blood when fat is being broken down. Ketones may help radiation work better&#xD;
      and may starve your tumor because it is thought that some brain tumors can not use ketones to&#xD;
      grow and can only use sugar or glucose to grow.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of inducing ketosis</measure>
    <time_frame>6 weeks</time_frame>
    <description>Ketosis measured by serum beta-hydroxybuterate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of progression free survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Modified Atkins Ketogenic Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modified Atkins Ketogenic Diet in combination with Temodar and Radiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified Atkins Ketogenic Diet</intervention_name>
    <description>Less than 20 grams of carbohydrates per day</description>
    <arm_group_label>Modified Atkins Ketogenic Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed primary malignant glioma, Grade III or IV&#xD;
&#xD;
          -  No uncontrolled infection or other active malignancy or chronic systemic immune&#xD;
             therapy.&#xD;
&#xD;
          -  ECOG performance status &lt; 3.&#xD;
&#xD;
          -  Life expectancy &gt; three months.&#xD;
&#xD;
          -  Adequate labs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of genetic disorder of fat metabolism.&#xD;
&#xD;
          -  Type 2 diabetes diagnosed with a hemoglobin A1C &gt; 6.4&#xD;
&#xD;
          -  Allergic to dairy or lactose intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rekha Chaudhary, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Rekha Chaudhary</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>brain tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 14, 2022</submitted>
    <returned>April 14, 2022</returned>
    <submitted>April 18, 2022</submitted>
    <returned>January 17, 2023</returned>
    <submitted>April 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03278249
org study id: UCCI-BRAIN-16-01
nct id: NCT03278249
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to see if people can produce ketones in their blood
      with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your
      blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are
      produced in the blood when fat is being broken down. Ketones may help radiation work better
      and may starve your tumor because it is thought that some brain tumors can not use ketones to
      grow and can only use sugar or glucose to grow.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of inducing ketosis
time frame: 6 weeks
description: Ketosis measured by serum beta-hydroxybuterate
measure: Assessment of progression free survival
time frame: 6 months
measure: Assessment of survival
time frame: 2 years
arm group label: Modified Atkins Ketogenic Diet
arm group type: Experimental
description: Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
intervention type: Other
intervention name: Modified Atkins Ketogenic Diet
description: Less than 20 grams of carbohydrates per day
arm group label: Modified Atkins Ketogenic Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rekha Chaudhary, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Rekha Chaudhary
investigator title: Associate Professor of Medicine
mesh term: Glioblastoma
mesh term: Glioma
sharing ipd: No
submitted: February 14, 2022
returned: April 14, 2022
submitted: April 18, 2022
returned: January 17, 2023
submitted: April 10, 2023