Development of a Dietary Intervention Model Based on Genetic Data as an Implementation of a Healthy Lifestyle in the Management of Systemic Lupus Erythematosus Patients
NCT ID: NCT07183007
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-09-21
2026-03-31
Brief Summary
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* What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on disease activity?
* What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on quality of life Researchers would compare dietary intervention based on genetic data to a no intervention to see if dietary intervention based on genetic data improves disease activity and quality of life of SLE patients.
Participants will:
* Be checked for genetic test (HLA DQ2 and DQ8) as screening
* Be randomized to dietary intervention group or control group if has HLA DQ2 or DQ8 positive from screening
* Visit the clinic once every month for checkups and lab test if were randomized to dietary intervention group or control group
* Do food record as instructed if were randomized to dietary intervention group or control group
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dietary intervention based on genetic data
Dietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive
Low gluten diet
Systemic lupus erythematosus patients with HLA-DQ2 or DQ-8 positive will be randomized to dietary intervention group or control group. Those who are randomized to dietary intervention group will get dietary planning and intervention from a nutritionist with low gluten diet
Control group
Usual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive
No interventions assigned to this group
Interventions
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Low gluten diet
Systemic lupus erythematosus patients with HLA-DQ2 or DQ-8 positive will be randomized to dietary intervention group or control group. Those who are randomized to dietary intervention group will get dietary planning and intervention from a nutritionist with low gluten diet
Eligibility Criteria
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Inclusion Criteria
2. Age above 18 years
Exclusion Criteria
2. Refusal to participate in the study.
3. Pregnancy.
4. Breastfeeding.
5. Already on a specific autoimmune-related diet.
6. Patients with severe medical conditions (active cancer, stage V chronic kidney disease, or acute heart failure).
7. Patients taking corticosteroids equivalent to more than 20 mg/dL prednisone
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Dr. dr. Alvina Widhani, Sp.PD, KAI
Associate Professor
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Facility Contacts
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Role: backup
Other Identifiers
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KET948/UN2F1/ETIK/PPM0002/2025
Identifier Type: -
Identifier Source: org_study_id
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