Lupus Erythematosus, Systemic
Conditions
Brief summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acids (EPA plus DHA)
Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Inert soybean oil capsules identical in appearance to the active supplement.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 to 45 years * Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR/ACR classification criteria * Remission or low disease activity, defined as SLEDAI-2K ≤ 4 * On stable doses of hydroxychloroquine and/or glucocorticoids (≤10 mg/day of prednisone or equivalent) for at least 8 weeks prior to enrollment * Ability and willingness to provide written informed consent * Willingness to maintain usual dietary patterns and physical activity levels throughout the study period
Exclusion criteria
* Current use of omega-3 fatty acid supplements or use within the previous 3 months * Pregnancy or lactation * Presence of severe infection, neoplastic disease, or diabetes mellitus * Known allergy or intolerance to fish oil or soybean oil * Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Telomere length | Baseline and 12 weeks | Change in leukocyte telomere length assessed by quantitative polymerase chain reaction (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | Baseline and 12 weeks | Change in serum inflammatory markers, including interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP), assessed using standard laboratory methods. |
| Oxidative stress markers | Baseline and 12 weeks | Change in oxidative stress markers, including malondialdehyde (MDA) and total antioxidant capacity (TAC), measured by validated biochemical assays. |
| Lipid profile | Baseline and 12 weeks | Change in serum lipid profile, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides. |
| Fatty acid profiles | Baseline and 12 weeks | Fatty acids will be converted to fatty acid methyl esters (FAME) via transesterification, assessing by gas chromatograph. |
Contacts
CONTACTCarolina Nicoletti Ferreira
Outcome results
None listed