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

NCT07183007 | Not Yet Recruiting

• 1 other identifier: KET948/UN2F1/ETIK/PPM0002/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; dietary intervention; nutrigenomic; HLA-DQ2; HLA-DQ8

Outcome Measures

Primary Outcomes (2)

• Systemic Lupus Erythematosus (SLE) Disease Activity

  Measurement of Systemic Lupus Erythematosus disease activity using The Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX SLEDAI). Minimal score is 0 and maximal score is 32. Score 0-1 indicate remission; 2-5 indicate mild disease activity; 6-9 indicate moderate disease activity; 10-13 indicate severe disease activity; and ≥14 indicate very severe disease activity

  baseline, 1 month after intervention and 3 months after intervention

• Lupus Quality of life

  Measurement of the Quality of Life (QOL) of Systemic Lupus Erythematosus patient using the LupusQOL, a disease-specific, 34-item instrument that assesses eight domains: physical health pain, planning, intimate relationship, emotional health, burden to others, body image, and fatigue. Each item uses a 5-point Likert scale (0-4), with domain scores calculated by averaging item responses within each domain, dividing by four, and multiplying by 100 to yield scores ranging from 0 (worst) to 100 (best QoL)

  baseline, 1 month after intervention and 3 months after intervention

Secondary Outcomes (4)

• Fatigue score

  baseline, 1 month after intervention, and 3 months after intervention

• Physical activity

  baseline, 1 month after intervention, and 3 months after intervention

• Sleep quality

  baseline, 1 month after intervention, and 3 months after intervention

• Anxiety and depression

  baseline, 1 month after intervention, and 3 months after intervention

Study Arms (2)

Dietary intervention based on genetic data

ACTIVE COMPARATOR

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

Other: Low gluten diet

Control group

NO INTERVENTION

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

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

Dietary intervention based on genetic data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of active infection.
• Refusal to participate in the study.
• Pregnancy.
• Breastfeeding.
• Already on a specific autoimmune-related diet.
• Patients with severe medical conditions (active cancer, stage V chronic kidney disease, or acute heart failure).
• Patients taking corticosteroids equivalent to more than 20 mg/dL prednisone

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Location

Related Publications (1)

• Widhani A, Wardhani WI, Shahab SN, Kasih M, Cahyanur R, Yunihastuti E, Ahani AR. Dietary Intervention for Systemic Lupus Erythematosus patients based on HLA-DQ2 and DQ8 genotyping (DISH): a protocol for a randomised controlled study. Lupus Sci Med. 2025 Nov 24;12(2):e001833. doi: 10.1136/lupus-2025-001833.

  PMID: 41290265 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 19, 2025
• Study Start: September 21, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)