The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients with Schizophrenia
The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients with Schizophrenia
NCT ID: NCT06789471 Phase: NA Status: COMPLETED Enrollment: 24 Completion: 2024-10-01
Conditions
Overweight and Obesity, Metabolic Cardiovascular Syndrome, Schizophrenia, Disorganized
Interventions
psyllium husk
Summary
The research employs a quasi-experimental design, aiming to enroll 24 hospitalized patients with schizophrenia from 2hospitals in the central region, guided by G Power calculations. Participants will be carefully matched based on gender, age (within 5 years), and the same hospital. They will be divided into two groups using a single-masked randomized allocation method. The experimental group (psyllium husk group) will consume 10 grams of psyllium husk daily, split into two doses, taken about an hour before meals. The control group will receive standard treatment. The intervention will last for 12 weeks.
Inclusion criteria involve a schizophrenia diagnosis as per DSM-V criteria, age between 20 and 65 years, and a body mass index (BMI) of 24 kg/m² or higher, or meeting more than three indicators of metabolic syndrome. Exclusion criteria include medications for glucose, blood pressure, or lipid levels reduction, significant comorbidities like cardiovascular diseases or cancer, a history of neurogenic bowel obstruction or post-weight loss surgery, and patients with severe psychiatric symptoms impeding cooperation.
Each patient will undergo measurements for weight, waist circumference, body mass index, and blood biochemical analysis, encompassing fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and glycated hemoglobin (HbA1c) before the intervention and after 12 weeks.
Primary Outcome
Body Weight in Kilograms