About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Omega-3 Fatty Acids (EPA plus DHA)
Dietary supplementOral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
Placebo
Dietary supplementInert soybean oil capsules identical in appearance to the active supplement.
Treatment groups
Trial outcomes
Primary outcomes
Telomere length
Change in leukocyte telomere length assessed by quantitative polymerase chain reaction (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio.
Secondary outcomes
Inflammatory markers
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
Change in oxidative stress markers, including malondialdehyde (MDA) and total antioxidant capacity (TAC), measured by validated biochemical assays.
Lipid profile
Change in serum lipid profile, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides.
Fatty acid profiles
Fatty acids will be converted to fatty acid methyl esters (FAME) via transesterification, assessing by gas chromatograph.
Locations
Sponsors and contacts
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