Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 80
- Primary Endpoint
- Telomere length
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Omega-3 Supplementation
Intervention: Omega-3 Fatty Acids (EPA plus DHA) (Dietary Supplement)
Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Telomere length
Time Frame: 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 Outcomes
- Fatty acid profiles(Baseline and 12 weeks)
- Inflammatory markers(Baseline and 12 weeks)
- Oxidative stress markers(Baseline and 12 weeks)
- Lipid profile(Baseline and 12 weeks)
Investigators
Bruno Gualano
PhD
University of Sao Paulo