Structured Medical Nutrition Therapy to Lower inflammation in schizophrenia patients on antipsychotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates structured Medical Nutrition Therapy (MNT) for adults with schizophrenia or schizoaffective disorder who are hospitalized and on stable antipsychotic therapy. Participants receive individualized nutrition assessment, targeted dietary changes, education, and ongoing monitoring, aiming to reduce systemic inflammation as measured by the Systemic Inflammation Index (SII). The trial compares structured MNT to standard nutritional care over a defined period, using the SII as a biomarker of inflammatory status. Eligibility includes adults 18-60 with DSM-5 schizophrenia spectrum diagnoses, stable antipsychotics, hospitalization at a specific center, and ability to consent. Exclusion criteria include active infections, autoimmune diseases, malignancy, significant organ disease, pregnancy, current systemic anti-inflammatory medications, and concurrent interventional studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia
  Medan, Indonesia Recruiting

Study contacts

• Study coordinator: Zsizsi Akbarinda
• Email: zsizsiakbarinda12@gmail.com
• Phone: +6281260993322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.