The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- PANSS score changes
Study Overview
Brief Summary
This experiment was conducted to investigate the improvement of hypoglycemic index diet (LGIT) as a potential new intervention scheme for treatment-resistant schizophrenia, and to further explore the mechanism of efficacy.
Detailed Description
A low glycemic index diet (LGIT) is a modification of a ketogenic diet (KD) that includes low carbohydrate, medium protein, and high fat intake.It is a potential new intervention for refractory schizophrenia.The possible mechanism is that relatively low and stable blood sugar levels trigger the brain to start applying fat metabolism, helping to compensate for impaired GABA levels in the brain.KD can effectively treat refractory epilepsy, and its therapeutic effect on epilepsy is comparable to that of antiepileptic drugs, which have been written into the treatment guidelines as a good synergist and mood stabilizer in schizophrenia and various mental disorders.Therefore, it can be assumed that LGIT has a certain effect on the positive symptoms of schizophrenia as a synergistic agent.In this study, 80 patients with schizophrenia were randomly divided into two groups: LGIT diet and normal diet.The changes of PANSS and blood lipid before and after treatment were analyzed. Transcranial magnetic stimulation (TMS) was used to evaluate the gaba-mediated cortical excitability of patients to further explore the mechanism of efficacy.
Experimental design:
1)Experimental scheme:
- Sample estimation and selection of cases: although not find LGIT to treat schizophrenia scale research for reference, but in an article published in 2018 KD the curative effect of treatment of refractory epilepsy in children and adherence of Meta analysis, Du Ailing from 1989 to 2018 were analyzed such as relevant information received 503 cases, termination of the experiments of the main causes of poor adherence to patients and family members, the loss rate of about 10%.Therefore, 80 cases meeting the inclusion criteria and exclusion criteria were included in this study, all of which were inpatients from huangpu district mental health center in Shanghai. The patients were divided into LGIT group (L) with 40 cases and normal diet group (N) with 40 cases by random number table method.
- Inclusion criteria:
- Meet the diagnostic criteria of schizophrenia in icd-10, and score ≥4 in any item of p1-7 in PANSS scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria:
- •①Meet the diagnostic criteria of schizophrenia in icd-10, and score ≥4 in any item of p1-7 in PANSS scale.
- •② Meet the diagnostic criteria for treatable schizophrenia: in the past 5 years to three drugs and the appropriate dose and course of antipsychotic drugs (three drugs at least two chemical structures are different) poor response; Adverse reactions of patients who cannot tolerate antipsychotic drugs; Even with adequate maintenance treatment or preventive treatment, the patient still relapses or deteriorates.
Exclusion Criteria
- •Patients with the following diseases: fatty acid transport or oxidation defects, ketone body synthesis or decomposition defects, mitochondrial diseases, serious liver diseases, pyruvate carboxylase defects, porphyria, carnitine deficiency, some immunodeficiency diseases, organic acid urine; ② Patients with bleeding tendency, severe hypertension and severe heart, liver, lung, kidney failure, severe epilepsy patients; ③ Serious history of alcohol and drug abuse, addiction; ④ Extremely excited restless patients;Patients using implantable electronic devices.
Outcomes
Primary Outcomes
PANSS score changes
Time Frame: 12 weeks
Observe and record the patient's symptoms before dietary treatment and 4, 8, and 12 weeks of treatment. The PANSS score is used for evaluation. The lower the score, the better the effect is obtained.
Secondary Outcomes
- Changes in BMI(12 weeks)
Investigators
Jijun Wang
professor of medicine
Shanghai Jiao Tong University School of Medicine