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Effectiveness of Ketogenic Diet in MELAS Syndrome

ConditionsMELAS SyndromeKetogenic Dieting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ketogenic diet

    Dietary supplement

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: self pre-and post-controlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Clinical Symptom Score in 1 Year

According to the newcastle mitochondrial disease adult scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.

Time frame
Baseline, 1 month, 3 months, 6 months and 12 months
2

Change from Baseline Biochemical indicators in 1 Year

Blood glucose

Time frame
Baseline, 1 month, 3 months, 6 months and 12 months
3

Change from Baseline Biochemical indicators in 1 Year

keto, lactate and pyruvate monitoring

Time frame
Baseline, 1 month, 3 months, 6 months and 12 months
4

Hamilton Anxiety Scale (HAMA)

Change from Baseline Cognitive Function in 1 Year. Cognitive function was assessed using "Fepsy" software

Time frame
Baseline, 1 month, 3 months, 6 months and 12 months

Secondary outcomes

1

Demographic Information and Medical History Collection

Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: