Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism
研究概览
简要总结
In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Each participant will take two capsules daily for a duration of 90 days, with the active group receiving capsules containing 1000 mg of fish oil each. All participants will be instructed to maintain their usual diet, lifestyle, and medication regimen.
At the beginning and end of the study, various health assessments, including lipid panels and C-reactive protein measurements, will be conducted. Additionally, DNA samples will be collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading to the creation of four distinct subgroups: those receiving omega-3 with and without polymorphisms, and those receiving placebo with and without polymorphisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75;
- •( LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
排除标准
- •Personal history of cardiovascular disease or hight risk (≥ 20%);
- •Triglycerides (TG) ≥ 400 mg/dL;
- •Obesity (Body Mass Index > 32 kg/m2);
- •Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months;
- •Diabetes mellitus;
- •Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
结局指标
主要结局
the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism
时间窗: 90 days
the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
次要结局
- the percent change in hsCRP(90 days)
- the percent change in total cholesterol the percent change in total cholesterol(90 days)
- the percent change in serum triglycerides(90 days)
- the percent change in High-density lipoprotein cholesterol(90 days)