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Effectiveness of Ketogenic Diet in MELAS Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06013397
Recruitment Status : Not yet recruiting
First Posted : August 28, 2023
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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


Condition or disease Intervention/treatment Phase
MELAS Syndrome Ketogenic Dieting Dietary Supplement: Ketogenic diet Not Applicable

Detailed Description:

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Ketogenic Diet in the Treatment of Mitochondrial Encephalomyopathy With Lactic Acidosis and Stroke-like Episodes(MELAS)
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : June 1, 2038
Estimated Study Completion Date : June 1, 2038

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: self pre-and post-control
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
 Dietary Supplement: Ketogenic diet
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Clinical Symptom Score in 1 Year [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    According to the newcastle mitochondrial disease adult scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.

  2. Change from Baseline Biochemical indicators in 1 Year [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Blood glucose

  3. Change from Baseline Biochemical indicators in 1 Year [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    keto, lactate and pyruvate monitoring

  4. Hamilton Anxiety Scale (HAMA) [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Change from Baseline Cognitive Function in 1 Year. Cognitive function was assessed using "Fepsy" software

  5. Hamilton Depression Scale(HAMD [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software

  6. Wechsler Intelligence Scale(WISC) [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software

  7. Mini-mental State Examination(MMSE) [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Change from Baseline Cognitive Function in 1 Year . Cognitive function was assessed using "Fepsy" software

  8. Change from Baseline Diagnostic Examination in 1 Year [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ]
    Cranial MRI（multimodal） Scalp EEG to evaluate posterior head α rhythm, discharge index, interictal epileptic discharges


Secondary Outcome Measures :
  1. Demographic Information and Medical History Collection [ Time Frame: Baseline ]
    Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet the diagnostic criteria of MELAS and have received MELAS standard therapy but are not satisfied with the therapeutic effect, and voluntarily underwent ketogenic therapy

Exclusion Criteria:

  • Diseases with porphyria and disturbances in fatty acid transport and oxidation, severe electrolyte metabolism abnormalities, severe hemodynamic instability, acute respiratory infections, uncontrolled systemic infections, severe liver and renal failure, cholesterolemia (>300mgdl), abnormal coagulation, acute pancreatitis, eating disorders, ketogenic diet intolerance, significant weight loss, poor compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013397


Contacts
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Contact: Yao Ding, doctor 13588015954 zjdingyao@zju.edu.cn

Locations
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China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Contact: Yao Ding, doctor    13588015854    zjdingyao@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Shuang Wang, doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT06013397    
Other Study ID Numbers: 2023-0366
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MELAS Syndrome
Syndrome
Disease
Pathologic Processes
Mitochondrial Encephalomyopathies
Mitochondrial Myopathies
Muscular Diseases
Musculoskeletal Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Neuromuscular Diseases
Vascular Diseases
Cardiovascular Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Mitochondrial Diseases