xml: <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/NCT06013397</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0366</org_study_id>
      <nct_id>NCT06013397</nct_id>
    </id_info>
    <brief_title>Effectiveness of Ketogenic Diet in MELAS Syndrome</brief_title>
    <official_title>Clinical Trial of Ketogenic Diet in the Treatment of Mitochondrial Encephalomyopathy With Lactic Acidosis and Stroke-like Episodes(MELAS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 goal of this clinical trial is to evaluate the effectiveness of ketogenic diet in&#xD;
        patients with MELAS syndrome. The main questions it aims to answer are:&#xD;
  &#xD;
        Clarify the curative effects of ketogenic diet in the treatment of MELAS disease.&#xD;
  &#xD;
        Prevent the aggravation of MELAS disease, and improve the quality of life of patients.&#xD;
  &#xD;
        Provide reliable evidence-based medical basis for the clinical application of ketogenic diet&#xD;
        in the treatment of MELAS syndrome patients.&#xD;
  &#xD;
        The clinical data of the participants treated with ketogenic diet will be collected,&#xD;
        including the completion of ketogenic diet and clinical data at the start of treatment and&#xD;
        after 1 month, 3 months, 6 months and 12 months&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ketogenic diet initiation and follow-up:&#xD;
  &#xD;
          1. Before starting ketogenic diet treatment, patients with abnormal indexes such as liver,&#xD;
             kidney, lipid, humoral immunity, hematuria, routine biochemical, electrolyte, trace&#xD;
             elements and bone metabolism should be excluded, energy and nutrients should be&#xD;
             calculated according to their height and weight, and patients will be taught with&#xD;
             ketogenic diet treatment education&#xD;
  &#xD;
          2. Patients were initiated ketogenic diet after a short period of fasting (fasting no more&#xD;
             than 48 hours). After treatment was initiated, 13 of the calculated target energy was&#xD;
             given on the first day, 23 of the target energy was given on the second day, and the&#xD;
             target amount was reached on the third day. Nutritionists made appropriate adjustments&#xD;
             to the target energy according to the level of blood keto measured by patients&#xD;
  &#xD;
          3. Weekly follow-up via telemedicine system or social media, outpatient follow-up at the&#xD;
             initiation of ketogenic therapy and at 1 month, 3 months, 6 months, and 12 months&#xD;
             respectively. Outpatient follow-up was done in a joint clinic with a dietitian and a&#xD;
             neurologist to evaluate the effects and side effects of ketogenic therapy on a compliant&#xD;
             diet and related clinical examinations&#xD;
  &#xD;
        Clinical data collection:&#xD;
  &#xD;
          1. Demographic information and Medical history collection Gender, age, education level age&#xD;
             of onset, genetic test, drug use, past history, personal history, family history&#xD;
  &#xD;
          2. Clinical symptom collection According to the Newcastle Mitochondrial Disease Adult&#xD;
             Scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.&#xD;
  &#xD;
          3. Biochemical indicators Blood glucose, keto, lactate and pyruvate monitoring, dietary&#xD;
             status, dietary ratio changes, energy changes, weight changes&#xD;
  &#xD;
          4. Cognitive function assessment Cognitive function was assessed using Fepsy software&#xD;
  &#xD;
          5. Diagnostic Examination Cranial MRI, scalp EEG&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2038</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2038</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>Change from Baseline Clinical Symptom Score in 1 Year</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>According to the newcastle mitochondrial disease adult scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline Biochemical indicators in 1 Year</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Blood glucose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline Biochemical indicators in 1 Year</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>keto, lactate and pyruvate monitoring</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Change from Baseline Cognitive Function in 1 Year. Cognitive function was assessed using &quot;Fepsy&quot; software</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale(HAMD</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using &quot;Fepsy&quot; software</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wechsler Intelligence Scale(WISC)</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using &quot;Fepsy&quot; software</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-mental State Examination(MMSE)</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using &quot;Fepsy&quot; software</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline Diagnostic Examination in 1 Year</measure>
      <time_frame>Baseline, 1 month, 3 months, 6 months and 12 months</time_frame>
      <description>Cranial MRI（multimodal） Scalp EEG to evaluate posterior head α rhythm, discharge index, interictal epileptic discharges</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic Information and Medical History Collection</measure>
      <time_frame>Baseline</time_frame>
      <description>Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>MELAS Syndrome</condition>
    <condition>Ketogenic Dieting</condition>
    <arm_group>
      <arm_group_label>self pre-and post-control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It is a self pre- and post-control, which compares the outcomes of the ketogenic diet with the status that did not receive ketogenic treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ketogenic diet</intervention_name>
      <description>Ketogenic diet (KD) is a high-fat, low-carbohydrate and moderate protein diet pattern, suitable for refractory epilepsy, glucose carrier protein 1 deficiency, pyruvate dehydrogenase deficiency, tumors and some genetic metabolic diseases. The ketogenic diet has been used to treat epilepsy for nearly 100 years, and its safety has been recognized by the medical community. In 2015, the ketogenic diet was included in the &quot;Clinical Diagnosis and Treatment Guidelines - Epilepsy Volume&quot; and became a commonly used treatment for refractory epilepsy.</description>
      <arm_group_label>self pre-and post-control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who meet the diagnostic criteria of MELAS and have received MELAS standard&#xD;
               therapy but are not satisfied with the therapeutic effect, and voluntarily underwent&#xD;
               ketogenic therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diseases with porphyria and disturbances in fatty acid transport and oxidation, severe&#xD;
               electrolyte metabolism abnormalities, severe hemodynamic instability, acute&#xD;
               respiratory infections, uncontrolled systemic infections, severe liver and renal&#xD;
               failure, cholesterolemia (&gt;300mgdl), abnormal coagulation, acute pancreatitis, eating&#xD;
               disorders, ketogenic diet intolerance, significant weight loss, poor compliance&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shuang Wang, doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yao Ding, doctor</last_name>
      <phone>13588015954</phone>
      <email>zjdingyao@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yao Ding, doctor</last_name>
        <phone>13588015854</phone>
        <email>zjdingyao@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>May 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>MELAS Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013397
  org study id: 2023-0366
  nct id: NCT06013397
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the effectiveness of ketogenic diet in
        patients with MELAS syndrome. The main questions it aims to answer are:
  
        Clarify the curative effects of ketogenic diet in the treatment of MELAS disease.
  
        Prevent the aggravation of MELAS disease, and improve the quality of life of patients.
  
        Provide reliable evidence-based medical basis for the clinical application of ketogenic diet
        in the treatment of MELAS syndrome patients.
  
        The clinical data of the participants treated with ketogenic diet will be collected,
        including the completion of ketogenic diet and clinical data at the start of treatment and
        after 1 month, 3 months, 6 months and 12 months
  Ketogenic diet initiation and follow-up:
  
          1. Before starting ketogenic diet treatment, patients with abnormal indexes such as liver,
             kidney, lipid, humoral immunity, hematuria, routine biochemical, electrolyte, trace
             elements and bone metabolism should be excluded, energy and nutrients should be
             calculated according to their height and weight, and patients will be taught with
             ketogenic diet treatment education
  
          2. Patients were initiated ketogenic diet after a short period of fasting (fasting no more
             than 48 hours). After treatment was initiated, 13 of the calculated target energy was
             given on the first day, 23 of the target energy was given on the second day, and the
             target amount was reached on the third day. Nutritionists made appropriate adjustments
             to the target energy according to the level of blood keto measured by patients
  
          3. Weekly follow-up via telemedicine system or social media, outpatient follow-up at the
             initiation of ketogenic therapy and at 1 month, 3 months, 6 months, and 12 months
             respectively. Outpatient follow-up was done in a joint clinic with a dietitian and a
             neurologist to evaluate the effects and side effects of ketogenic therapy on a compliant
             diet and related clinical examinations
  
        Clinical data collection:
  
          1. Demographic information and Medical history collection Gender, age, education level age
             of onset, genetic test, drug use, past history, personal history, family history
  
          2. Clinical symptom collection According to the Newcastle Mitochondrial Disease Adult
             Scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.
  
          3. Biochemical indicators Blood glucose, keto, lactate and pyruvate monitoring, dietary
             status, dietary ratio changes, energy changes, weight changes
  
          4. Cognitive function assessment Cognitive function was assessed using Fepsy software
  
          5. Diagnostic Examination Cranial MRI, scalp EEG
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from Baseline Clinical Symptom Score in 1 Year
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: According to the newcastle mitochondrial disease adult scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.
  measure: Change from Baseline Biochemical indicators in 1 Year
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Blood glucose
  measure: Change from Baseline Biochemical indicators in 1 Year
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: keto, lactate and pyruvate monitoring
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Change from Baseline Cognitive Function in 1 Year. Cognitive function was assessed using "Fepsy" software
  measure: Hamilton Depression Scale(HAMD
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software
  measure: Wechsler Intelligence Scale(WISC)
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software
  measure: Mini-mental State Examination(MMSE)
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software
  measure: Change from Baseline Diagnostic Examination in 1 Year
  time frame: Baseline, 1 month, 3 months, 6 months and 12 months
  description: Cranial MRI（multimodal） Scalp EEG to evaluate posterior head α rhythm, discharge index, interictal epileptic discharges
  measure: Demographic Information and Medical History Collection
  time frame: Baseline
  description: Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history
  arm group label: self pre-and post-control
  arm group type: Experimental
  description: It is a self pre- and post-control, which compares the outcomes of the ketogenic diet with the status that did not receive ketogenic treatment
  intervention type: Dietary Supplement
  intervention name: Ketogenic diet
  description: Ketogenic diet (KD) is a high-fat, low-carbohydrate and moderate protein diet pattern, suitable for refractory epilepsy, glucose carrier protein 1 deficiency, pyruvate dehydrogenase deficiency, tumors and some genetic metabolic diseases. The ketogenic diet has been used to treat epilepsy for nearly 100 years, and its safety has been recognized by the medical community. In 2015, the ketogenic diet was included in the "Clinical Diagnosis and Treatment Guidelines - Epilepsy Volume" and became a commonly used treatment for refractory epilepsy.
  arm group label: self pre-and post-control
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Shuang Wang, doctor
  role: Principal Investigator
  affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
  last name: Yao Ding, doctor
  phone: 13588015954
  email: zjdingyao@zju.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: MELAS Syndrome
  mesh term: Syndrome