Omega-3 Fatty Acids (EPA plus DHA)
Dietary SupplementOral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
NCT Number: NCT07393399
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
Inert soybean oil capsules identical in appearance to the active supplement.
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Change in oxidative stress markers, including malondialdehyde (MDA) and total antioxidant capacity (TAC), measured by validated biochemical assays.
Time frame: Baseline and 12 weeks
Change in serum lipid profile, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides.
Time frame: Baseline and 12 weeks
Fatty acids will be converted to fatty acid methyl esters (FAME) via transesterification, assessing by gas chromatograph.
Contact information is provided by the study sponsor or research team.
University of Sao Paulo
Other
Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Acronym: SLE-OMEGA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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