MELAS SyndromeNCT06013397
Effectiveness of Ketogenic Diet in MELAS Syndrome
A study testing Ketogenic diet in people with MELAS Syndrome and Ketogenic Dieting, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MELAS Syndrome, Ketogenic Dieting
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Jun 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yao Ding, doctor, 13588015854, zjdingyao@zju.edu.cn
About this study
Official title: Clinical Trial of Ketogenic Diet in the Treatment of Mitochondrial Encephalomyopathy With Lactic Acidosis and Stroke-like Episodes(MELAS)
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
Read the detailed description
Ketogenic diet initiation and follow-up:
- 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
- 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
- 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:
- Demographic information and Medical history collection Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history
- Clinical symptom collection According to the Newcastle Mitochondrial Disease Adult Scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.
- Biochemical indicators Blood glucose, keto, lactate and pyruvate monitoring, dietary status, dietary ratio changes, energy changes, weight changes
- Cognitive function assessment Cognitive function was assessed using Fepsy software
- Diagnostic Examination Cranial MRI, scalp EEG
- Conditions
- MELAS Syndrome, Ketogenic Dieting
- Being tested
- Ketogenic diet
- Medical subject headings
- MELAS Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, 6 months and 12 months
Change from Baseline Biochemical indicators in 1 Year
Blood glucose
Measured: Baseline, 1 month, 3 months, 6 months and 12 months
Change from Baseline Biochemical indicators in 1 Year
keto, lactate and pyruvate monitoring
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jun 2038 (estimated)
- Study completion1 Jun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MELAS SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuang Wang, doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013397
- Sponsor's protocol ID
- 2023-0366
- Status last verified
- Apr 2023
- First submitted
- 11 May 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Ketogenic Diet in the Treatment of Mitochondrial Encephalomyopathy With Lactic Acidosis and Stroke-like Episodes(MELAS)
- ClinicalTrials.gov ID
- NCT06013397
- Acronym / sponsor ID
- 2023-0366
- Conditions
- MELAS Syndrome, Ketogenic Dieting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2038 (estimated)
- Study completion
- 1 Jun 2038 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Ketogenic diet initiation and follow-up:
- 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
- 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
- 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:
- Demographic information and Medical history collection Gender, age, education level age of onset, genetic test, drug use, past history, personal history, family history
- Clinical symptom collection According to the Newcastle Mitochondrial Disease Adult Scale(NMDAS), including migraine headaches, seizures, stroke-like episodes and etc.
- Biochemical indicators Blood glucose, keto, lactate and pyruvate monitoring, dietary status, dietary ratio changes, energy changes, weight changes
- Cognitive function assessment Cognitive function was assessed using Fepsy software
- Diagnostic Examination Cranial MRI, scalp EEG
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self pre-and post-control | Experimental | Dietary Supplement: Ketogenic dietIt is a self pre- and post-control, which compares the outcomes of the ketogenic diet with the status that did not receive ketogenic treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietKetogenic 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. | Dietary supplement | self pre-and post-control |
Primary outcome
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.
Change from Baseline Biochemical indicators in 1 Year
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months
Blood glucose
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
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
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
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
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
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
1 secondary outcome
Demographic Information and Medical History Collection
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuang Wang, doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with MELAS Syndrome and Ketogenic Dieting, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Ding, doctor (13588015954, zjdingyao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Clinical Symptom Score in 1 Year (time frame: Baseline, 1 month, 3 months, 6 months and 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.