NCT06789471Completed
The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients with Schizophrenia
The Effects of Psyllium Seed on Body Weight and Metabolic Syndrome Indicators in Patients
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 23 Dec 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Ru-Shin Zhang
- Diseases
- Schizophrenia, Obesity
- NCT number
- NCT06789471
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 1 May 2024 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exclude those who use blood sugar-lowering, blood pressure-lowering, and blood-lipid-lowering drugs.
Other illness
- 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.
- History of grain allergy, asthma, etc.
Other
- Those with obvious mental symptoms who are unable to cooperate.
- Persons subject to a declaration of auxiliary guardianship.
Who the study is looking for
- 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%.
Age in the registry: 20 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taichung Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.