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The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia

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ClinicalTrials.gov Identifier: NCT04302636
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jijun Wang, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Refractory Schizophrenia Dietary Supplement: Low glycemic index diet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: The hypoglycemic index diet group

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.
Dietary Supplement: Low glycemic index diet
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.

No Intervention: General diet group
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 Measures :
  1. Subtractive rate of PANSS scale [ Time Frame: 12 weeks ]
    Obvious effect (PANSS score reduction rate >50%), effective (PANSS score reduction rate 25-50%), invalid (PANSS score reduction rate <25%).


Secondary Outcome Measures :
  1. Metabolic indicators improved [ Time Frame: 12 weeks ]
    There are significant differences in the changes of blood lipid and blood glucose.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302636


Locations
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China, Shanghai
Shanghai Huangpu District Mental Health Center
Shanghai, Shanghai, China, 200023
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Jijun Wang, professor of medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04302636    
Other Study ID Numbers: HKM201919
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jijun Wang, Shanghai Jiao Tong University School of Medicine:
Schizophrenia
Low-glycemic Idex Diet
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders