NCT04302636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

March 8, 2020

Last Update Submit

November 9, 2021

Conditions

Refractory Schizophrenia

Keywords

SchizophreniaLow-glycemic Idex Diet

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Changes in BMI

    12 weeks

Other Outcomes (5)

  • Observe changes in total cholesterol

    12 weeks

  • Changes in RBANS score

    12 weeks

  • Observe changes in triglycerides

    12 weeks

  • +2 more other outcomes

Study Arms (2)

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.

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.

Interventions

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.

The hypoglycemic index diet group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Huangpu District Mental Health Center

Shanghai, Shanghai Municipality, 200023, China

Location

MeSH Terms

Conditions

Schizophrenia, Treatment-ResistantSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 10, 2020

Study Start

September 24, 2019

Primary Completion

March 31, 2022

Study Completion

May 31, 2022

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

CN(1)