Effectiveness of Ketogenic Diet in MELAS Syndrome

NCT06013397 | Not Yet Recruiting

• 1 other identifier: 2023-0366
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

MELAS Syndrome; Ketogenic Dieting

Outcome Measures

Primary Outcomes (8)

• 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.

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

• Change from Baseline Biochemical indicators in 1 Year

  Blood glucose

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

• Change from Baseline Biochemical indicators in 1 Year

  keto, lactate and pyruvate monitoring

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

• Hamilton Anxiety Scale (HAMA)

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

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

• Hamilton Depression Scale(HAMD

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

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

• Wechsler Intelligence Scale(WISC)

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

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

• Mini-mental State Examination(MMSE)

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

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

• Change from Baseline Diagnostic Examination in 1 Year

  Cranial MRI（multimodal） Scalp EEG to evaluate posterior head α rhythm, discharge index, interictal epileptic discharges

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

Secondary Outcomes (1)

• Demographic Information and Medical History Collection

  Baseline

Study Arms (1)

self pre-and post-control

EXPERIMENTAL

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

Interventions

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.

self pre-and post-control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

MELAS Syndrome

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shuang Wang, doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Ding, doctor

CONTACT

13588015954; zjdingyao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 1, 2038
• Study Completion (Estimated): June 1, 2038
• Last Updated: August 28, 2023

Record last verified: 2023-04

Locations

CN (1)