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临床试验/NCT07393399
NCT07393399尚未招募不适用

Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial

University of Sao Paulo0 个研究点目标入组 80 人开始时间: 2026年7月1日最近更新:
干预措施

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

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

Experimental

干预措施: Omega-3 Fatty Acids (EPA plus DHA) (Dietary Supplement)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Gualano

PhD

University of Sao Paulo

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