Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Telomere length
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Omega-3 Supplementation
干预措施: Omega-3 Fatty Acids (EPA plus DHA) (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Telomere length
时间窗: 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.
次要结局
- 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)
研究者
Bruno Gualano
PhD
University of Sao Paulo
