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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDINA KEUMALA SARI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modification Diet

    Other intervention

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

  • Hospitalized Diet

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Hospitalized DietSham comparator 1 intervention
Group B: Modification DietExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DINA KEUMALA SARI

Lead sponsor

Universitas Sumatera Utara

Sponsor institution