<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/NCT04477161</url>
  </required_header>
  <id_info>
    <org_study_id>Ketone in PD</org_study_id>
    <secondary_id>IRB201901326</secondary_id>
    <secondary_id>OCR24402</secondary_id>
    <nct_id>NCT04477161</nct_id>
  </id_info>
  <brief_title>Effect of Ketone Esters in Parkinson's Disease</brief_title>
  <official_title>Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      Ketones esters have shown to improve mitochondrial function and are currently use to enhanced&#xD;
      functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of&#xD;
      neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side&#xD;
      effects and effect of oral ketone esters in Patients with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's Disease (PD) is a debilitating progressive neurodegenerative disorder, second in&#xD;
      frequency only to Alzheimer's disease, affecting around 10 million people worldwide. PD is&#xD;
      characterized by loss of dopaminergic cells in substantia nigra and the accumulation of Lewy&#xD;
      bodies. There is no disease modifying treatment or cure for the disease and management&#xD;
      strategies focus on symptomatic treatment. One of the proposed mechanisms for the&#xD;
      dopaminergic neurons degeneration in sporadic Parkinson's disease cases is related to&#xD;
      compromise cellular bioenergetics, resulting in excessive production of reactive oxygen&#xD;
      species (ROS) that leads to oxidative stress. Numerous studies have identified mitochondrial&#xD;
      dysfunction as the central pathological features of both genetic and sporadic PD.&#xD;
      Mitochondrial dysfunction can also increase inflammation which is associated with PD and Lewy&#xD;
      Body formation. Elevated plasma ketones have been shown to enhance energy reserves, ATP&#xD;
      levels and the expression of many enzymes involved in multiple metabolic pathways in the&#xD;
      mitochondria. This pilot study aims to assess the effect of an exogenous ketone supplement on&#xD;
      functional performance in people with PD. Changes in inflammatory makers will also be&#xD;
      assessed. Participants will ingest the exogenous ketone supplement four times per day for&#xD;
      four weeks. Participants will undergo neurological, functional, and cognitive assessments&#xD;
      prior to and after the four-week intervention. Dietitians will follow up with participants&#xD;
      weekly for compliance and counseling. Diet will be assessed throughout the study using the&#xD;
      automated self-administered 24-hour dietary recall. After the four week intervention, a&#xD;
      two-week &quot;washout&quot; period will be observed before reassessing functional and cognitive&#xD;
      performance again.&#xD;
&#xD;
      Additionally, the study would like to establish the extent to which the use of Ketone esters&#xD;
      impact the gut microbiota. Gut microbita composition in PD has been associated with symptoms&#xD;
      and treatment efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2019</start_date>
  <completion_date type="Actual">November 5, 2020</completion_date>
  <primary_completion_date type="Actual">November 5, 2020</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>
    <intervention_model_description>pilot, prospective, single-arm, single-center study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in serum Ketones</measure>
    <time_frame>Baseline up to 4 months</time_frame>
    <description>by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Ketosis</condition>
  <arm_group>
    <arm_group_label>Ketone Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ketone Ester Elite endurance Nutrition Drink</intervention_name>
    <description>Subjects will take one bottle four times daily for four weeks</description>
    <arm_group_label>Ketone Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stool Sample</intervention_name>
    <description>Subjects will provide a stool sample at 2 timepoints.</description>
    <arm_group_label>Ketone Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician-diagnosed Parkinson's Disease&#xD;
&#xD;
          -  40-75 years of age&#xD;
&#xD;
          -  On stable dopaminergic therapy&#xD;
&#xD;
          -  Willing and able to complete the informed consent form in English&#xD;
&#xD;
          -  Willing to consume the study supplement four times each day during the 4-week&#xD;
             intervention period&#xD;
&#xD;
          -  Willing to complete all dietary recalls over approximately 6 weeks&#xD;
&#xD;
          -  Willing to complete all daily and weekly questionnaires throughout the six weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet the above criteria&#xD;
&#xD;
          -  Atypical or secondary Parkinsonism&#xD;
&#xD;
          -  BMI &gt;30&#xD;
&#xD;
          -  Rheumatological or other inflammatory conditions&#xD;
&#xD;
          -  Following of the ketogenic diet&#xD;
&#xD;
          -  History of ulcer disease&#xD;
&#xD;
          -  History of irritable bowel disorder or irritable bowel syndrome&#xD;
&#xD;
          -  Currently taking any medication that could affect stool formation.&#xD;
&#xD;
          -  Diagnosis of Diabetes mellitus Type 1 or Type 2&#xD;
&#xD;
          -  Currently smoking (including vaping) tobacco products.&#xD;
&#xD;
          -  Women who are lactating, know that they are pregnant, or are attempting to get&#xD;
             pregnant.&#xD;
&#xD;
          -  Note: a pregnancy test will be administered prior to initiating consumption of the&#xD;
             study supplement. Women who are pregnant will be withdrawn from the study at that&#xD;
             time.&#xD;
&#xD;
          -  Use of another investigational product within 3 months of the initial visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fixel Institute for Neurological Diseases</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>parkinson disease</keyword>
  <keyword>ketosis</keyword>
  <keyword>microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Ketosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participant data will be shared with collaborators on project here at the University of Florida and only de-identified data will be released with IRB approval.</ipd_description>
  </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/NCT04477161
org study id: Ketone in PD
secondary id: IRB201901326
secondary id: OCR24402
nct id: NCT04477161
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ketones esters have shown to improve mitochondrial function and are currently use to enhanced
      functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of
      neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side
      effects and effect of oral ketone esters in Patients with Parkinson's disease.
Parkinson's Disease (PD) is a debilitating progressive neurodegenerative disorder, second in
      frequency only to Alzheimer's disease, affecting around 10 million people worldwide. PD is
      characterized by loss of dopaminergic cells in substantia nigra and the accumulation of Lewy
      bodies. There is no disease modifying treatment or cure for the disease and management
      strategies focus on symptomatic treatment. One of the proposed mechanisms for the
      dopaminergic neurons degeneration in sporadic Parkinson's disease cases is related to
      compromise cellular bioenergetics, resulting in excessive production of reactive oxygen
      species (ROS) that leads to oxidative stress. Numerous studies have identified mitochondrial
      dysfunction as the central pathological features of both genetic and sporadic PD.
      Mitochondrial dysfunction can also increase inflammation which is associated with PD and Lewy
      Body formation. Elevated plasma ketones have been shown to enhance energy reserves, ATP
      levels and the expression of many enzymes involved in multiple metabolic pathways in the
      mitochondria. This pilot study aims to assess the effect of an exogenous ketone supplement on
      functional performance in people with PD. Changes in inflammatory makers will also be
      assessed. Participants will ingest the exogenous ketone supplement four times per day for
      four weeks. Participants will undergo neurological, functional, and cognitive assessments
      prior to and after the four-week intervention. Dietitians will follow up with participants
      weekly for compliance and counseling. Diet will be assessed throughout the study using the
      automated self-administered 24-hour dietary recall. After the four week intervention, a
      two-week "washout" period will be observed before reassessing functional and cognitive
      performance again.

      Additionally, the study would like to establish the extent to which the use of Ketone esters
      impact the gut microbiota. Gut microbita composition in PD has been associated with symptoms
      and treatment efficacy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: pilot, prospective, single-arm, single-center study
primary purpose: Other
masking: None (Open Label)
measure: Changes in serum Ketones
time frame: Baseline up to 4 months
description: by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months
arm group label: Ketone Intervention
arm group type: Experimental
description: Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks
intervention type: Dietary Supplement
intervention name: Ketone Ester Elite endurance Nutrition Drink
description: Subjects will take one bottle four times daily for four weeks
arm group label: Ketone Intervention
intervention type: Other
intervention name: Stool Sample
description: Subjects will provide a stool sample at 2 timepoints.
arm group label: Ketone Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Ketosis
sharing ipd: No
ipd description: Participant data will be shared with collaborators on project here at the University of Florida and only de-identified data will be released with IRB approval.