Evaluation of the Efficacy of Phospholipid-Bound Omega-3 Versus Omega-3 Alone in Patients With Hypertriglyceridemia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Reduction in Triglyceride Levels
研究概览
简要总结
Hypertriglyceridemia is a significant risk factor for cardiovascular diseases. Omega-3 fatty acids have been shown to reduce triglyceride levels, and their combination with phospholipids could offer additional benefits in improving lipid profiles and inflammatory markers. This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence on the benefits of this combination in improving lipid profiles and reducing inflammation, which could have a significant impact on clinical practices and future dietary recommendations.
详细描述
This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence of the benefits of this combination in improving lipid profiles and reducing inflammation, which could significantly impact clinical practices and future dietary recommendations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In addition to the parties commonly masked in this clinical trial(e.g., participants, investigators, and outcome assessors), other parties be masked include:
- Data Analysts: If feasible, data analysts will be blinded to the intervention groups during data analysis to reduce bias in interpreting results.
- Study Coordinators or Site Staff: Those responsible for enrolling participants or managing study logistics will be masked to intervention assignments to prevent unintentional influence on participant behavior.
- Pharmacists or Treatment Preparers: Pharmacists will be blinded to the allocation of active versus placebo treatments
- Regulatory Reviewers or Monitors: External reviewers or monitors who audit the study will be masked to treatment allocation to ensure unbiased oversight.
- Statistical Reviewers for Interim Analyses: the statisticians conducting these will be masked to group allocations to preserve trial integrity.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 to 65 years.
- •Triglyceride levels ≥ 150 mg/dL and ≤ 500 mg/dL.
- •Signed informed consent.
排除标准
- •Use of omega-3 supplements in the last 3 months.
- •Use of any lipid-lowering medication.
- •Known allergy to the components of the treatment.
- •Uncontrolled chronic diseases (e.g., renal failure, liver disease).
- •Any type of cancer.
- •Undergoing treatment for HIV.
- •Pregnancy or breastfeeding.
- •Use of substances or prescribed medications that may increase triglyceride levels (e.g., estrogens, atypical antipsychotics, etc.). -
结局指标
主要结局
Reduction in Triglyceride Levels
时间窗: 12 weeks
Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.
次要结局
- Reduction in Inflammatory Markers(12 weeks)
- Improvement in HOMA-IR Index(12 weeks)
- Improvement in Omega Index(12 weeks)