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The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia

Primary Purpose

Refractory Schizophrenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low glycemic index diet
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Schizophrenia focused on measuring Schizophrenia, Low-glycemic Idex Diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. 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.

    • Age 18-65.
  2. 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.

Sites / Locations

  • Shanghai Huangpu District Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The hypoglycemic index diet group

General diet group

Arm Description

Patients in the experimental group ate two portions of food each day.This diet will last for 12 weeks. Food provided by the canteen: one egg for breakfast;Lunch and dinner are 50g of rice with all the dishes. Dietary nutrition and supplementary food: according to the weight and height of the patient, the daily energy required was calculated, which was divided into six levels: 1400kcal, 1600kcal, 1800kcal, 2000kcal, 2200kcal and 2400kcal.The six corresponding nutritional auxiliary food powders are: 20g-30g-40g-50g-60g-70 g.The suspension was prepared in the proportion of 160ml warm water poured into 55 grams and given to the patient.

The LGIT diet of the experimental group consisted of 55% fat, 30% protein and 15% carbohydrate, and the glycemic index of the food was limited to less than 50. The meal was prepared by a public nutritionist who evaluated the nutritional composition of the inpatients provided by the canteen and then added or subsumed the compound nutrition powder.

Outcomes

Primary Outcome Measures

PANSS score changes
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 Outcome Measures

Changes in BMI
Measure the height of the patient, observe and record the weight change of the patient before the diet treatment and 12 weeks after the treatment, and calculate the BMI according to the formula "BMI (kg/m2)=weight (kg)/height (m)2". The closer the BMI is to the normal value, the better the effect obtained.

Full Information

First Posted
March 8, 2020
Last Updated
November 9, 2021
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04302636
Brief Title
The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
Official Title
The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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. ③ Age 18-65. 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. Withdrawal criteria: ① Complete the 12-week test process; ② LGIT patients in the experimental group and the normal diet control group continued to use the original drugs throughout the experiment. If the type or dose of antipsychotics changed due to the recurrence of the disease, they would withdraw from the experiment. ③ The patient can not tolerate the situation of diet treatment, autonomous request to withdraw. Before treatment, at the end of the 4th week, the 8th week and the 12th week, venous blood was extracted from the elbow for four times, and the positive and negative symptom syndrome scale (PANSS), Hamilton anxiety scale (HAMA) and Hamilton depression scale (HAMD) were measured by two professional evalutors with blind evaluation.The neuropsychological state rating scale (RBANS) was used to assess changes in cognitive function before and after treatment.Transcranial magnetic stimulation (TMS) was used to assess changes in cortical excitability mediated by gaba-capable intermediate neurons in patients before and after treatment. Efficacy evaluation criteria: according to obvious effect (PANSS score reduction rate >50%), effective (PANSS score reduction rate 25-50%), invalid (PANSS score reduction rate <25%). the LGIT diet of the experimental group consisted of 55% fat, 30% protein and 15% carbohydrate, and the glycemic index of the food was limited to less than 50. The meal was prepared by a public nutritionist who evaluated the nutritional composition of the inpatients provided by the canteen and then added or subsumed the compound nutrition powder. 2)statistical treatment: SPSS21.0 statistical software package was used, measurement data were expressed as (x-±s), the mean level was 0.05, group t test was used for comparison before and after treatment, and correlation analysis was multiple stepwise regression analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Schizophrenia
Keywords
Schizophrenia, Low-glycemic Idex Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The hypoglycemic index diet group
Arm Type
Experimental
Arm Description
Patients in the experimental group ate two portions of food each day.This diet will last for 12 weeks. Food provided by the canteen: one egg for breakfast;Lunch and dinner are 50g of rice with all the dishes. Dietary nutrition and supplementary food: according to the weight and height of the patient, the daily energy required was calculated, which was divided into six levels: 1400kcal, 1600kcal, 1800kcal, 2000kcal, 2200kcal and 2400kcal.The six corresponding nutritional auxiliary food powders are: 20g-30g-40g-50g-60g-70 g.The suspension was prepared in the proportion of 160ml warm water poured into 55 grams and given to the patient.
Arm Title
General diet group
Arm Type
No Intervention
Arm Description
The LGIT diet of the experimental group consisted of 55% fat, 30% protein and 15% carbohydrate, and the glycemic index of the food was limited to less than 50. The meal was prepared by a public nutritionist who evaluated the nutritional composition of the inpatients provided by the canteen and then added or subsumed the compound nutrition powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low glycemic index diet
Intervention Description
The LGIT diet of the experimental group consisted of 55% fat, 30% protein and 15% carbohydrate, and the glycemic index of the food was limited to less than 50. The meal was prepared by a public nutritionist who evaluated the nutritional composition of the inpatients provided by the canteen and then added or subsumed the compound nutrition powder.
Primary Outcome Measure Information:
Title
PANSS score changes
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in BMI
Description
Measure the height of the patient, observe and record the weight change of the patient before the diet treatment and 12 weeks after the treatment, and calculate the BMI according to the formula "BMI (kg/m2)=weight (kg)/height (m)2". The closer the BMI is to the normal value, the better the effect obtained.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Observe changes in total cholesterol
Description
Before the diet treatment and after 12 weeks of treatment, test total cholesterol (mmol/L) and observe its changes.
Time Frame
12 weeks
Title
Changes in RBANS score
Description
Observe and record the changes in the patient's neuropsychological state before dietary treatment and after 12 weeks of treatment, and use RBANS for evaluation. The higher the score, the better the effect.
Time Frame
12 weeks
Title
Observe changes in triglycerides
Description
Before the diet treatment and after 12 weeks of treatment, test triglycerides (mmol/L) and observe its changes.
Time Frame
12 weeks
Title
Observe changes in total serum protein
Description
Before the diet treatment and after 12 weeks of treatment, test serum total protein (g/L), and observe its changes.
Time Frame
12 weeks
Title
Observe changes in fasting blood glucose
Description
Before the diet treatment and after 12 weeks of treatment, test fasting blood glucose (mmol/L), and observe its changes.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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. Age 18-65. 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.
Facility Information:
Facility Name
Shanghai Huangpu District Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200023
Country
China

12. IPD Sharing Statement

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The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia

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