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

NCT07696000 | Recruiting DMC

• 1 other identifier: USU Psychiatry Nutrition
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia / Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Between-Group Difference in Change of Systemic Inflammation Index

  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.

  aseline and end of intervention (4-6 weeks)

Study Arms (2)

Hospitalized Diet

SHAM COMPARATOR

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

Other: Hospitalized Diet

Modification Diet

EXPERIMENTAL

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

Other: Modification Diet

Interventions

Modification Diet OTHER

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

Modification Diet

Hospitalized Diet OTHER

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

Hospitalized Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• DINA KEUMALA SARI: lead

Study Sites (1)

Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia

Medan, Indonesia

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Zsizsi Akbarinda

CONTACT

+6281260993322; zsizsiakbarinda12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

ID (1)