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

NCT06789471 | Completed DMC

• 1 other identifier: 112033
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Metabolic Cardiovascular Syndrome; Schizophrenia, Disorganized

Outcome Measures

Primary Outcomes (3)

• Body Weight in Kilograms

  Measure body weight in the morning after waking up, with participants wearing light clothing and no shoes.

  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."

  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.

  At baseline (week 0) and at weeks 6 and 12 of the study.

Secondary Outcomes (1)

• 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, %)

  During weeks 0 and 12of the study

Study Arms (2)

Psyllium group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

psyllium husk DIETARY_SUPPLEMENT

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

Psyllium group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Men and women aged between 20 and 65 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia based on DSM-V criteria;
• Age between 20 and 65 years old
• Body mass index (BMI) of 24 kg/m² or higher or those who meet more than three indicators of metabolic syndrome
• Individuals with glycated hemoglobin (HbA1c) levels ranging from 5.7% to 6.4%.

You may not qualify if:

• Exclude those who use blood sugar-lowering, blood pressure-lowering, and blood-lipid-lowering drugs.
• 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.
• Those with obvious mental symptoms who are unable to cooperate.
• History of grain allergy, asthma, etc.
• Persons subject to a declaration of auxiliary guardianship.

Sponsors & Collaborators

• Ru-Shin Zhang: lead

Study Sites (1)

Taichung Hospital

Taichung, Taiwan, 403, Taiwan

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Schizophrenia, Disorganized

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Mei-Ling Lin

  HungKaungUniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: single-blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Taichung Hospital Nurse Practitioner

Model Details: . 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.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 23, 2025
• Study Start: May 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)