Schizophrenia / Schizoaffective DisorderNCT07696000
The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy
A study testing Modification Diet and Hospitalized Diet in people with Schizophrenia / Schizoaffective Disorder, run by DINA KEUMALA SARI at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia / Schizoaffective Disorder
- What is being tested?
- Modification Diet and Hospitalized Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia
Medan
About this study
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
- Being tested
- Modification Diet, Hospitalized Diet
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification DietOther
Diet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality.
Hospitalized DietOther
The control group received the standard hospital diet according to institutional nutritional care protocols.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Diet | Sham comparator | The control group received the standard hospital diet according to institutional nutritional care protocols. Receives: Other: Hospitalized Diet |
| Modification Diet | Experimental | Diet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality. Receives: Other: Modification Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: aseline and end of intervention (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia / Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DINA KEUMALA SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696000
- Sponsor's protocol ID
- USU Psychiatry Nutrition
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy
- ClinicalTrials.gov ID
- NCT07696000
- Acronym / sponsor ID
- USU Psychiatry Nutrition
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DINA KEUMALA SARIUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Diet | Sham comparator | Other: Hospitalized DietThe control group received the standard hospital diet according to institutional nutritional care protocols. |
| Modification Diet | Experimental | Other: Modification DietDiet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modification DietDiet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality. | Other | Modification Diet |
| Hospitalized DietThe control group received the standard hospital diet according to institutional nutritional care protocols. | Other | Hospitalized Diet |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modification Diet and Hospitalized Diet in people with Schizophrenia / Schizoaffective Disorder, run by DINA KEUMALA SARI at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zsizsi Akbarinda (+6281260993322, zsizsiakbarinda12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-Group Difference in Change of Systemic Inflammation Index (time frame: aseline and end of intervention (4-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.