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Effect of ketogenic diet combined with olanzapine on metabolic disorder and cognitive symptoms in schizophrenia

Effect of ketogenic diet combined with olanzapine on metabolic disorder and cognitive symptoms in schizophrenia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037076
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

control group:base diet with olanzapine
Intervention group :ketogenic diet with olanzapine

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-55 years old, male or female; 2. The patients who met the DSM-V diagnostic criteria of schizophrenia; PANSS score >= 60; 3. Patients who have been taking olanzapine for at least 6 months (the dose has not changed within at least 1 month); 4. Patients with other antipsychotics were stable for at least one month; 5. Fasting blood glucose of 6.1-6.9 mmol / L or patients with blood glucose > 7.8 mmol / L and BMI >= 27 kg / m2 in two hours after oral administration of 75g glucose in glucose tolerance test.

Exclusion criteria

Exclusion criteria: 1. Patients with severe digestive, cardiovascular, respiratory, liver and urinary system or genetic metabolic diseases with ketogenic diet taboo (such as complex 2-5 fatty acid metabolic disorder in etc deficiency) and congenital immunodeficiency disease; 2. Patients who are not suitable for ketogenic diet therapy; 3. Patients with type 1 and type 2 diabetes or taking antidiabetic drugs; 4. Patients with impaired liver function (ALT > 2 times the upper limit of normal value); 5. Patients with impaired renal function (creatinine > 150 umol/L); 6. Patients with impaired islet function (acute or chronic pancreatitis); 7. Patients with severe hypertension (systolic blood pressure > 180mmhg, diastolic blood pressure > 100mmhg); 8. Patients taking diet pills; 9. Pregnant or lactating women; 10. Patients with substance abuse.

Design outcomes

Primary

MeasureTime frame
PANSS score;

Secondary

MeasureTime frame
Intestinal flora detection;Parameters of glucose and lipid metabolism;RBANS score;Blood biochemical indicators;

Countries

China

Contacts

Public ContactPeng Yanmin

Shanghai Mental Health Center

amee.pong@hotmail.com+86 13818328417

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026