Clinical trial NCT06789471: The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients with Schizophrenia
Official title: The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Metabolic Cardiovascular Syndrome
Schizophrenia, Disorganized
Lead sponsor: Hung Kaung University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: . 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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
4. Individuals with glycated hemoglobin (HbA1c) levels ranging from 5.7% to 6.4%.

Exclusion Criteria:

1. Exclude those who use blood sugar-lowering, blood pressure-lowering, and blood-lipid-lowering drugs.
2. Patients with major internal and external diseases such as cardiovascular disease, cancer, patients who have experienced neuropathic intestinal obstruction, patients after bariatric surgery, or those who have experienced choking.
3. Those with obvious mental symptoms who are unable to cooperate.
4. History of grain allergy, asthma, etc.
5. Persons subject to a declaration of auxiliary guardianship.

Primary outcomes:
measure: Body Weight in Kilograms
timeFrame: At baseline (week 0) and at weeks 6 and 12 of the study.
measure: Waist Circumference in cm
timeFrame: At baseline (week 0) and at weeks 6 and 12 of the study.
measure: Body Mass Index (BMI) in (kg/m²)
timeFrame: At baseline (week 0) and at weeks 6 and 12 of the study.
Secondary outcomes:
measure: 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, %)
timeFrame: During weeks 0 and 12of the study
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Hospital
Study officials:
affiliation: HungKaungUniversity
name: Mei-Ling Lin
role: STUDY_DIRECTOR
References: