An interventional study of psyllium husk in Overweight and Obesity, Metabolic Cardiovascular Syndrome and Schizophrenia, Disorganized, sponsored by Ru-Shin Zhang. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Ru-Shin Zhang · Not applicable, Interventional, and Supportive care
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.
The study adopts a quasi-experimental research design and plans to include 24 hospitalized patients with schizophrenia from 2 hospitals in the central region, based on G Power calculations. This study will be matched based on gender, age (within 10 years), and the same hospital.The participants 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, divided into two doses, and taken approximately one hour before meals. The control group will receive standard treatment, and the intervention will last for 12 weeks. Inclusion criteria are: 1. Diagnosis of schizophrenia based on DSM-V criteria; 2. Age between 20 and 65 years old; 3. Body mass index (BMI) of 24 kg/m² or higher or those who meet more than three indicators of metabolic syndrome. Exclusion criteria are medications for lowering blood glucose, blood pressure, or lipid levels, significant comorbidities such as cardiovascular diseases or cancer, history of neurogenic bowel obstruction or post-weight loss surgery, and patients with prominent psychiatric symptoms who cannot cooperate. Each patient will undergo measurements of weight, waist circumference, body mass index, and blood biochemical analysis data, including 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
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 24 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
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Exclusion Criteria:
The experimental group (psyllium husk group) will consume 10 grams of psyllium husk daily, divided into two doses, and taken approximately one hour before meals for 12 weeks.
Dietary Supplement: psyllium husk
The control group will receive standard treatment, not use psyllium and the intervention will last for 12 weeks.
Psyllium husk, derived from the seeds' husks of the Plantago ovata plant, is a plant-based fiber supplement.
Body Weight in Kilograms
Measure body weight in the morning after waking up, with participants wearing light clothing and no shoes.
Time frame: At baseline (week 0) and at weeks 6 and 12 of the study.
Waist Circumference in cm
Waist circumference will be measured to evaluate the impact of psyllium husk intervention on abdominal fat distribution in patients with schizophrenia. Measurements will be conducted using a flexible, non-stretchable measuring tape, positioned horizontally around the abdomen at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Participants will stand upright, with feet close together, arms at their sides, and abdomen relaxed during the measurement. The values will be recorded in centimeters (cm). The experimental group will consume 10 grams of psyllium husk daily, while the control group will receive standard treatment. Changes in waist circumference will be analyzed within and between groups."
Time frame: At baseline (week 0) and at weeks 6 and 12 of the study.
Body Mass Index (BMI) in (kg/m²)
Body mass index (BMI) will be calculated to evaluate the impact of psyllium husk intervention on overall body composition in patients with schizophrenia. BMI is expressed in kilograms per square meter (kg/m²) and will be calculated using the formula: weight (kg) divided by height squared (m²). Weight will be measured with a calibrated digital scale, ensuring participants wear light clothing and no shoes. Height will be measured using a wall-mounted stadiometer, with participants standing barefoot, heels together, arms at their sides, and head positioned in the Frankfurt horizontal plane. These measurements will be used to calculate BMI, which will be recorded and analyzed for changes within and between groups.
Time frame: At baseline (week 0) and at weeks 6 and 12 of the study.
Metabolic syndrome indicators ex (Fasting Glucose (mg/dL) Total Cholesterol (mg/dL) Triglycerides (mg/dL) High-Density Lipoprotein Cholesterol (HDL-C, mg/dL) Low-Density Lipoprotein Cholesterol (LDL-C, mg/dL) Glycated Hemoglobin (HbA1c, %)
Each time, 5 c.c. of blood is drawn from the arm vein for the following tests and their respective units: Fasting Glucose (mg/dL) Total Cholesterol (mg/dL) Triglycerides (mg/dL) High-Density Lipoprotein Cholesterol (HDL-C, mg/dL) Low-Density Lipoprotein Cholesterol (LDL-C, mg/dL) Glycated Hemoglobin (HbA1c, %) Blood collection requires at least 8 hours of fasting and is performed by professional medical technologists or nursing staff to ensure accurate results.
Time frame: During weeks 0 and 12of the study
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Sep 2024, 4 months.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 4 months is below that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psyllium husk