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

NCT06789471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-01-23

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

psyllium husk

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

Sponsors & Collaborators

  • Ru-Shin Zhang

    lead OTHER

Principal Investigators

  • Mei-Ling Lin · HungKaungUniversity

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-09-30
Completion
2024-10-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789471 on ClinicalTrials.gov