Not Yet RecruitingNot Applicable

Effectiveness of Ketogenic Diet in MELAS Syndrome

China100 participantsStarted 2023-09-01

Plain-language 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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline Clinical Symptom Score in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Change from Baseline Biochemical indicators in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Change from Baseline Biochemical indicators in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Hamilton Anxiety Scale (HAMA)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Hamilton Depression Scale(HAMD

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Wechsler Intelligence Scale(WISC)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Mini-mental State Examination(MMSE)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Trial details

NCT IDNCT06013397

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2038-06-01

Contact for this trial

Yao Ding, doctor

13588015954 zjdingyao@zju.edu.cn

View on ClinicalTrials.gov More MELAS Syndrome trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline Clinical Symptom Score in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Change from Baseline Biochemical indicators in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Change from Baseline Biochemical indicators in 1 Year

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Hamilton Anxiety Scale (HAMA)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Hamilton Depression Scale(HAMD

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Wechsler Intelligence Scale(WISC)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months

Mini-mental State Examination(MMSE)

Timeframe: Baseline, 1 month, 3 months, 6 months and 12 months