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NCT Number: NCT07696000

The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy

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.

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Key information

Conditions

Schizophrenia / Schizoaffective Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia

Medan, Indonesia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modification Diet

Other

Diet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality.

Hospitalized Diet

Other

The control group received the standard hospital diet according to institutional nutritional care protocols.

Primary outcomes

Between-Group Difference in Change of Systemic Inflammation Index

Time frame: aseline and end of intervention (4-6 weeks)

Systemic Inflammation Index (SII) will be calculated using the formula: platelet count × neutrophil count / lymphocyte count. The primary endpoint is the difference in the change in SII from baseline to the end of the intervention between the structured Medical Nutrition Therapy group and the standard hospital diet group.

Study contacts

Contact information is provided by the study sponsor or research team.

Zsizsi Akbarinda

CONTACT

[email protected]

+6281260993322

Sponsors and collaborators

Lead sponsor

DINA KEUMALA SARI

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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