The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients Wit… (NCT07696000) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy
Indonesia100 participantsStarted 2026-07-01
Plain-language summary
Patients with schizophrenia receiving long-term antipsychotic therapy are at increased risk of chronic low-grade inflammation and metabolic disturbances, which contribute to poor physical health outcomes and increased cardiovascular morbidity. Structured Medical Nutrition Therapy (MNT), consisting of individualized nutrition assessment, dietary intervention, nutrition education, and regular monitoring, has the potential to improve dietary quality and modulate systemic inflammation. This study aims to evaluate the effect of Structured Medical Nutrition Therapy on the Systemic Inflammation Index (SII), a novel inflammatory biomarker derived from neutrophil, lymphocyte, and platelet counts, in patients with schizophrenia receiving antipsychotic therapy. It is hypothesized that patients receiving structured MNT will demonstrate a greater reduction in SII compared with those receiving standard nutritional care, supporting the integration of evidence-based nutritional interventions into the comprehensive management of schizophrenia to improve metabolic and inflammatory outcomes.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged 18-60 years. Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Receiving stable antipsychotic therapy for at least 4 weeks before enrollment. Hospitalized at Prof. Dr. M. Ildrem Psychiatric Hospital during the study period.
Able to consume an oral diet. Willing to participate and provide written informed consent (or consent provided by a legally authorized representative when applicable).
Exclusion Criteria:
Acute infection, autoimmune disease, malignancy, or other inflammatory conditions that may influence the Systemic Inflammation Index (SII).
Chronic liver disease, end-stage renal disease, or severe heart failure. Pregnancy or breastfeeding. Current use of systemic corticosteroids, immunosuppressive agents, or anti-inflammatory medications that could affect inflammatory biomarkers.
Receiving enteral or parenteral nutrition. Participation in another interventional clinical trial within the previous 3 months.
Incomplete clinical or laboratory data. Inability to complete the intervention or follow-up assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-Group Difference in Change of Systemic Inflammation Index
Timeframe: aseline and end of intervention (4-6 weeks)