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

Not Applicable

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT07183007
• Lead Sponsor: Indonesia University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-28
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-13
• Last Update Submitted: 2025-09-13
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-09-21
• Primary Completion: 2025-12
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systemic Lupus Erythematosus (SLE) Disease Activity	baseline, 1 month after intervention and 3 months after intervention	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
Lupus Quality of life	baseline, 1 month after intervention and 3 months after intervention	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)

Secondary Outcome Measures

Name	Time	Method
Fatigue score	baseline, 1 month after intervention, and 3 months after intervention	Fatigue score is measured using the Fatigue Severity Scale, a 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7-point scale with 1 = strongly disagree and 7= strongly agree.; The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Physical activity	baseline, 1 month after intervention, and 3 months after intervention	Measuring physical activity using short form of International Physical Activity Questionnaire. This questionnaire provides information on the time spent walking, in vigorous- and moderate intensity activity and in sedentary activity in the last 7 days to estimate total physical activity in MET-min/week and time spent sitting
Sleep quality	baseline, 1 month after intervention, and 3 months after intervention	Measuring sleep quality using Pittsburgh Sleep Quality Index (PSQI). It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale.; A global sum of "5" or greater indicates a "poor" sleeper. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Anxiety and depression	baseline, 1 month after intervention, and 3 months after intervention	Measuring anxiety and depression score using Hospital Anxiety Depression Scale (HADS). The HADS is a 14-item questionnaire consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items. Respondents rate their feelings over the past week on a 4-point Likert scale, where: 0 = Not at all; 1 = Occasionally; 2 = Often; 3 = Most of the time. The total score can range from 0 to 42, combining both anxiety and depression scores. Each subscale (anxiety and depression) can score between 0 and 21.; Interpretation of Scores: 0-7= Normal; 8-10: Mild symptoms; 11-21: Moderate to severe symptoms.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, Jakarta Special Capital Region, Indonesia