<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/NCT03790436</url>
  </required_header>
  <id_info>
    <org_study_id>HS-17-01011</org_study_id>
    <nct_id>NCT03790436</nct_id>
  </id_info>
  <brief_title>Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet</brief_title>
  <official_title>A Pilot Study on the Feasibility and Tolerability of Betaquik, a Special Medical Food Containing Medium Chain Triglycerides (MCT) as an Adjunct to the Dietary Management of Epilepsy and Quality of Life in Adults on the Modified Atkins Diet (MAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vitaflo International, Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <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 pilot study is to measure adherence and quality of life in adults with&#xD;
      intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use&#xD;
      medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot study is to measure adherence and quality of life in adults with&#xD;
      intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use&#xD;
      medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.&#xD;
&#xD;
      The participants dietitian will recommend an appropriate daily intake of Betaquik based on&#xD;
      individual requirements. Participants will be asked to gradually introduce Betaquik into the&#xD;
      diet up to the target volume advised by the dietitian. Participants will then incorporate the&#xD;
      target volume of Betaquik into their diet and gradually increase carbohydrate intake up to a&#xD;
      maximum tolerated level and continue on the management regime until the end of the 26-week&#xD;
      period. At the end of the 26-week period participants will undergo a Betaquik washout. In&#xD;
      order to mitigate any impact of Betaquik tapering dietary effectiveness and sustained&#xD;
      ketosis, carbohydrate intake will be reduced concurrently to the original 20-30 grams daily.&#xD;
      This will continue for an additional 26-weeks (totaling 52-weeks). Both Betaquik introduction&#xD;
      and tapers will occur under the direction of their dietitian with their daily intake under&#xD;
      weekly review for the duration of the study. Vitaflo International Ltd. will supply Betaquik&#xD;
      directly to the participants homes free of charge. Participants will be provided with a&#xD;
      28-day supply of Betaquik renewed every four weeks.&#xD;
&#xD;
      The objective of this study is to evaluate the acceptability, tolerance and adherence of the&#xD;
      MAD including MCT - Betaquik in participants with a diagnosis of epilepsy.&#xD;
&#xD;
      This is an exploratory pilot study to evaluate the gastrointestinal tolerance, palatability&#xD;
      and participant adherence, over a 52-week period, of the MAD with and without Betaquik, for&#xD;
      the dietary management of participants with epilepsy.&#xD;
&#xD;
      Participants will be asked to collect daily information on any incidence of the following for&#xD;
      the first 3 months and weekly thereafter:&#xD;
&#xD;
        -  Diarrhea and/or constipation as measured by stool frequency, color and consistency&#xD;
&#xD;
        -  Bloating and/or distension&#xD;
&#xD;
        -  Nausea and/or vomiting&#xD;
&#xD;
        -  Burping/flatulence/regurgitation&#xD;
&#xD;
        -  Abdominal discomfort/pain&#xD;
&#xD;
      If participants report any of the above then additional questions about the timing, duration,&#xD;
      cause and seriousness/severity of any adverse effects are to be recorded in the diary.&#xD;
&#xD;
      At the end of the 52-weeks all final questionnaires will be completed including those&#xD;
      assessing quality of life, clinical epilepsy status, dietary intake and adherence, Betaquik&#xD;
      and dietary carbohydrate intake and Betaquik tolerability. Final blood and urine samples will&#xD;
      be taken for clinical safety assessment and routine anthropometry measurements taken.&#xD;
&#xD;
      Statistics and Plans for Analysis: This is an exploratory pilot study and its primary aim is&#xD;
      to determine the acceptability, adherence and tolerance of the MAD with Betaquik as an&#xD;
      adjunct therapy. A t-test and chi-square will be used with the quantitative measures, under&#xD;
      the direction of a biostatistician. Qualitative measures will be described in a narrative&#xD;
      summarizing the study outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    We no longer have Ketogenic Dietician coverage/access.&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Adherence will be measured by the percent of time the participant drinks Betaquik averaged over 3 months. The participant will be considered adherent if they drink the required amount on more than 80% of the prescribed days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of Childhood Neurologic Disability Scale (ICNDS)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The Impact of Childhood Neurologic Disability Scale (ICNDS) measures factors that play a significant impact on the life of individuals with epilepsy: epilepsy, cognition, behavioral, and physical/neurologic function. Each factor has the same 11 questions applicable to the past 3 months of the individuals life which are scored 0 (not at all) to 3 (a lot). The maximum score in each factor is 33 and for the overall scale the score is 132; higher scores indicate greater impact. The Impact of Childhood Neurologic Disability Scale (ICNDS) includes a numeric scale of the child's overall quality of life ranging from 1 (poor) to 6 (excellent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview - Short Form</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The Zarit Burden Interview - Short Form has 12 items which are scored as 0 (never) to 4 (nearly always). The total score ranges 0 to 48. A score for no to mild caregiver burden has a score of 0-10, mild to moderate caregiver burden a score of 10-20, and high caregiver burden a score &gt;20.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Epilepsy</condition>
  <condition>Epilepsy Intractable</condition>
  <condition>Seizures</condition>
  <condition>Seizure Disorder</condition>
  <condition>Ketogenic Dieting</condition>
  <condition>Ketosis</condition>
  <arm_group>
    <arm_group_label>Betaquik</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Betaquik</intervention_name>
    <description>Study dietitian will advise each participant on target volume of Betaquik (45g MCT, 225mL Betaquik). Consuming too much MCT too quickly may cause gastrointestinal discomfort such as abdominal pain or diarrhea, this is related to its assimilation to the body. Any symptoms that do occur normally resolve in the majority of patients, and with time and persistence, GI tolerance is usually established.&#xD;
Therefore the study dietitian will advise on a gradual systematic introduction to minimize any adverse effects. The daily-tolerated amount will be divided into 3-4 equal portions, taken regularly throughout the day. subjects will be advised to always take Betaquik with food, as part of meals and snacks, to help promote gastrointestinal tolerance. The goal is within the first 4 weeks participants will have reached their tolerated target volume of Betaquik.</description>
    <arm_group_label>Betaquik</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of epilepsy; suffering from recurrent seizures (&gt; or equal to 2 seizures per&#xD;
             month) despite at least two anticonvulsant medication trials.&#xD;
&#xD;
          -  Aged 18 years and above.&#xD;
&#xD;
          -  Not on the ketogenic diet.&#xD;
&#xD;
          -  Absence of any metabolic or mitochondrial disorder that precludes the use of MCT and&#xD;
             the ketogenic diet.&#xD;
&#xD;
          -  Willingly given, written, informed consent from the patient or caregiver.&#xD;
&#xD;
          -  Ability to comply with study protocol and keep written records.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-compliant with previously recommended treatments.&#xD;
&#xD;
          -  Significantly underweight (BMI &lt;18.5), untreated dysphagia, or severe gastroesophageal&#xD;
             reflux.&#xD;
&#xD;
          -  Kidney disease, including history of nephrolithiasis.&#xD;
&#xD;
          -  Uncontrolled or untreated hypercholesterolemia (&gt;300mg/dL) or hypertriglyceridemia&#xD;
             (&gt;200mg/dL) within the last two years.&#xD;
&#xD;
          -  Prior use of Betaquik at any time for any duration.&#xD;
&#xD;
          -  Any serious medical, psychological, or social condition precluding the study&#xD;
             intervention.&#xD;
&#xD;
          -  Use of additional macro/micronutrient supplement during the study period, unless&#xD;
             clinical indicated and prescribed by the investigator (must be recorded electronic&#xD;
             medical records).&#xD;
&#xD;
          -  Women who are pregnant/breastfeeding at the start of the study or planning to become&#xD;
             pregnant during the study period.&#xD;
&#xD;
          -  N.B.: Women who become pregnant unexpectedly during this study may, in consultation&#xD;
             with their doctor, continue on the study's dietary product if they wish but will not&#xD;
             have any investigations that would not normally be carried out during pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Los Angeles County + University of Southern California (LAC+USC) Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Arthur Partikian</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT03790436
org study id: HS-17-01011
nct id: NCT03790436
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to measure adherence and quality of life in adults with
      intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use
      medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.
The purpose of this pilot study is to measure adherence and quality of life in adults with
      intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use
      medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.

      The participants dietitian will recommend an appropriate daily intake of Betaquik based on
      individual requirements. Participants will be asked to gradually introduce Betaquik into the
      diet up to the target volume advised by the dietitian. Participants will then incorporate the
      target volume of Betaquik into their diet and gradually increase carbohydrate intake up to a
      maximum tolerated level and continue on the management regime until the end of the 26-week
      period. At the end of the 26-week period participants will undergo a Betaquik washout. In
      order to mitigate any impact of Betaquik tapering dietary effectiveness and sustained
      ketosis, carbohydrate intake will be reduced concurrently to the original 20-30 grams daily.
      This will continue for an additional 26-weeks (totaling 52-weeks). Both Betaquik introduction
      and tapers will occur under the direction of their dietitian with their daily intake under
      weekly review for the duration of the study. Vitaflo International Ltd. will supply Betaquik
      directly to the participants homes free of charge. Participants will be provided with a
      28-day supply of Betaquik renewed every four weeks.

      The objective of this study is to evaluate the acceptability, tolerance and adherence of the
      MAD including MCT - Betaquik in participants with a diagnosis of epilepsy.

      This is an exploratory pilot study to evaluate the gastrointestinal tolerance, palatability
      and participant adherence, over a 52-week period, of the MAD with and without Betaquik, for
      the dietary management of participants with epilepsy.

      Participants will be asked to collect daily information on any incidence of the following for
      the first 3 months and weekly thereafter:

        -  Diarrhea and/or constipation as measured by stool frequency, color and consistency

        -  Bloating and/or distension

        -  Nausea and/or vomiting

        -  Burping/flatulence/regurgitation

        -  Abdominal discomfort/pain

      If participants report any of the above then additional questions about the timing, duration,
      cause and seriousness/severity of any adverse effects are to be recorded in the diary.

      At the end of the 52-weeks all final questionnaires will be completed including those
      assessing quality of life, clinical epilepsy status, dietary intake and adherence, Betaquik
      and dietary carbohydrate intake and Betaquik tolerability. Final blood and urine samples will
      be taken for clinical safety assessment and routine anthropometry measurements taken.

      Statistics and Plans for Analysis: This is an exploratory pilot study and its primary aim is
      to determine the acceptability, adherence and tolerance of the MAD with Betaquik as an
      adjunct therapy. A t-test and chi-square will be used with the quantitative measures, under
      the direction of a biostatistician. Qualitative measures will be described in a narrative
      summarizing the study outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.
time frame: up to 52 weeks
description: Adherence will be measured by the percent of time the participant drinks Betaquik averaged over 3 months. The participant will be considered adherent if they drink the required amount on more than 80% of the prescribed days.
measure: Impact of Childhood Neurologic Disability Scale (ICNDS)
time frame: up to 52 weeks
description: The Impact of Childhood Neurologic Disability Scale (ICNDS) measures factors that play a significant impact on the life of individuals with epilepsy: epilepsy, cognition, behavioral, and physical/neurologic function. Each factor has the same 11 questions applicable to the past 3 months of the individuals life which are scored 0 (not at all) to 3 (a lot). The maximum score in each factor is 33 and for the overall scale the score is 132; higher scores indicate greater impact. The Impact of Childhood Neurologic Disability Scale (ICNDS) includes a numeric scale of the child's overall quality of life ranging from 1 (poor) to 6 (excellent).
measure: Zarit Burden Interview - Short Form
time frame: up to 52 weeks
description: The Zarit Burden Interview - Short Form has 12 items which are scored as 0 (never) to 4 (nearly always). The total score ranges 0 to 48. A score for no to mild caregiver burden has a score of 0-10, mild to moderate caregiver burden a score of 10-20, and high caregiver burden a score >20.
arm group label: Betaquik
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Betaquik
description: Study dietitian will advise each participant on target volume of Betaquik (45g MCT, 225mL Betaquik). Consuming too much MCT too quickly may cause gastrointestinal discomfort such as abdominal pain or diarrhea, this is related to its assimilation to the body. Any symptoms that do occur normally resolve in the majority of patients, and with time and persistence, GI tolerance is usually established.
Therefore the study dietitian will advise on a gradual systematic introduction to minimize any adverse effects. The daily-tolerated amount will be divided into 3-4 equal portions, taken regularly throughout the day. subjects will be advised to always take Betaquik with food, as part of meals and snacks, to help promote gastrointestinal tolerance. The goal is within the first 4 weeks participants will have reached their tolerated target volume of Betaquik.
arm group label: Betaquik
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Arthur Partikian
investigator title: Associate Professor
mesh term: Epilepsy
mesh term: Seizures
mesh term: Drug Resistant Epilepsy