Refractory SchizophreniaNCT04302636
The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
A study testing Low glycemic index diet in people with Refractory Schizophrenia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- Low glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Huangpu District Mental Health Center
Shanghai, Shanghai Municipality, 200023
About this study
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.
Read the 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.
- Conditions
- Refractory Schizophrenia
- Being tested
- Low glycemic index diet
- Keywords
- Schizophrenia, Low-glycemic Idex Diet
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index dietDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| The hypoglycemic index diet group | Experimental | Patients in the experimental group ate two portions of food each day.This diet will last for 12 weeks.
1. Food provided by the canteen: one egg for breakfast;Lunch and dinner are 50g of rice with all the dishes.
2. 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. Receives: Dietary Supplement: Low glycemic index diet |
| General diet group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start24 Sep 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jijun Wang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302636
- Sponsor's protocol ID
- HKM201919
- Status last verified
- Nov 2021
- First submitted
- 8 Mar 2020
- Last updated
- 15 Nov 2021
- 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 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT04302636
- Acronym / sponsor ID
- HKM201919
- Conditions
- Refractory Schizophrenia
- Keywords
- Schizophrenia, Low-glycemic Idex Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 10 Mar 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The hypoglycemic index diet group | Experimental | Dietary Supplement: Low glycemic index dietPatients in the experimental group ate two portions of food each day.This diet will last for 12 weeks. 1. Food provided by the canteen: one egg for breakfast;Lunch and dinner are 50g of rice with all the dishes. 2. 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. |
| General diet group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Low glycemic index dietThe 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. | Dietary supplement | The hypoglycemic index diet group |
Primary outcome
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.
1 secondary outcome
Changes in BMI
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index diet in people with Refractory Schizophrenia, run by Shanghai Jiao Tong 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?
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: status not confirmed, as of the sponsor's last update on 15 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS score changes (time frame: 12 weeks). 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 15 Nov 2021.