A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percent Change in Triglyceride Levels
研究概览
简要总结
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of high-dose omega-3 PUFA supplementation in patients with dyslipidemia who carry a specific "unfavorable" genetic variant in the FADS1/FADS2 gene cluster. The study will compare lipid profile improvements and inflammatory markers between two cohorts: (1) homozygous (or high- risk) carriers of the FADS1/FADS2 variants and (2) non-carriers (wild-type). Investigators hypothesize that individuals with these variants will show a more pronounced reduction in triglyceride levels and inflammatory markers following high-dose omega-3 supplementation due to their diminished endogenous synthesis of long-chain PUFAs.
详细描述
Dyslipidemia is a key risk factor for cardiovascular disease, often characterized by elevated triglycerides, low HDL cholesterol, and/or high LDL cholesterol. Genetic variants in the fatty acid desaturase genes FADS1 and FADS2 can alter the conversion of shorter-chain polyunsaturated fatty acids into longer-chain forms (EPA, DHA), leading to suboptimal endogenous production of these beneficial fatty acids. Omega-3 supplements, especially EPA and DHA, have been shown to lower triglycerides and modulate inflammatory pathways. This study examines whether high-dose omega-3 supplementation (2-4 g/day) confers greater benefit for carriers of certain "unfavorable" FADS1/ FADS2 polymorphisms, potentially optimizing cardiovascular risk reduction in this genetically defined subgroup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).
- •On stable lipid-lowering therapy (e.g., statins) or lifestyle regimen for at least 4 weeks prior to enrollment, if applicable.
- •Willingness to undergo genetic testing for FADS1/FADS2 variants. For the FADS Variant Cohort: confirmed homozygous (or high-risk) polymorphisms in FADS1/FADS
- •For the Non-Variant Cohort: confirmed wild-type FADS genotype.
排除标准
- •Use of prescription omega-3 products or high-dose fish oil supplements within 4 weeks prior to enrollment.
- •Known hypersensitivity to fish or fish oil products. Significant renal or hepatic impairment, uncontrolled thyroid disease, or other comorbidities that may confound results.
- •Pregnancy or breastfeeding.
- •Inability or unwillingness to comply with study procedures.
研究组 & 干预措施
FADS Variant (Homozygous or High-Risk) Cohort
干预措施: High-dose omega-3 PUFA supplementation (Dietary Supplement)
Non-Variant (Control) Cohort
干预措施: High-dose omega-3 PUFA supplementation (Dietary Supplement)
结局指标
主要结局
Percent Change in Triglyceride Levels
时间窗: Week 12
Percent Change in LDL and HDL Cholesterol
时间窗: 12 weeks
次要结局
- Change in Inflammatory Markers hs-CRP mg/l(12 weeks)
- Any Adverse Events(12 weeks)
- Change in BMI(12 weeks)
- Change in Total Cholesterol mmol/l(12 weeks)
- Percent Change in Body Weight(12 weeks)
- Change in Non-HDL Cholesterol mmol/l(12 weeks)
- Change in Patient-Reported Quality of Life as Measured by the World Health Organization(12 weeks)