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

Sponsor
Indonesia University
Study ID
NCT07183007
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low gluten diet — OTHER
    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

Study Details

The goal of this clinical trial is to learn if dietary intervention based on genetic data benefits in the management of systemic lupus erythematosus patients. It will also learn about the safety of this intervention. The main questions it aims to answer are: * 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

Key Dates

First listed
Sep 19, 2025
Start date
Sep 21, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dietary intervention based on genetic data
    Dietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive
  • No Intervention: Control group
    Usual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive

Primary Outcome Measure

Systemic Lupus Erythematosus (SLE) Disease Activity [ Time Frame: baseline, 1 month after intervention and 3 months after intervention ]

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