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

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Low gluten diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07183007

KET948/UN2F1/ETIK/PPM0002/2025

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with systemic lupus erythematosus (SLE) diagnosed according to the 2019 EULAR/ACR criteria, registered as patients at RSCM.
2. Age above 18 years

Exclusion criteria

1. Presence of active infection.
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Dietary intervention based on genetic data

Active Comparator group

Description:

Dietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive

Treatment:

Other: Low gluten diet

Control group

No Intervention group

Description:

Usual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive