The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients with Schizophrenia

NCT ID: NCT06789471

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-10-01

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

Conditions

Overweight and Obesity; Metabolic Cardiovascular Syndrome; Schizophrenia, Disorganized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Psyllium group

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.

Group Type: EXPERIMENTAL

psyllium husk

Intervention Type: DIETARY_SUPPLEMENT

Psyllium husk, derived from the seeds' husks of the Plantago ovata plant, is a plant-based fiber supplement.

Control group

The control group will receive standard treatment, not use psyllium and the intervention will last for 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psyllium husk

Psyllium husk, derived from the seeds' husks of the Plantago ovata plant, is a plant-based fiber supplement.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ru-Shin Zhang

OTHER

Sponsor Role: lead

Responsible Party

Ru-Shin Zhang

Taichung Hospital Nurse Practitioner

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mei-Ling Lin

Role: STUDY_DIRECTOR

HungKaungUniversity

Locations

Taichung Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

112033

Identifier Type: -

Identifier Source: org_study_id