The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Between-Group Difference in Change of Systemic Inflammation Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Between-Group Difference in Change of Systemic Inflammation Index
时间窗: 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.
次要结局
未报告次要终点
研究者
DINA KEUMALA SARI
Prof
Universitas Sumatera Utara