Efficacy of Phospholipid Omega-3 (Ruby-O) Versus Conventional Omega-3 on the Omega-3 Index in Patients With Mixed Dyslipidemia: A 24-Week Randomized, Double-Blind, Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Omega-3 Index (O3I)
研究概览
简要总结
This study is a clinical trial designed to compare two forms of omega-3 supplements in adults with mixed dyslipidemia. Mixed dyslipidemia is a condition in which blood fat levels, such as triglycerides and cholesterol, are not within the recommended range and may increase the risk of cardiovascular disease.
Participants in this study will be randomly assigned to receive one of three study products: a phospholipid-based omega-3 supplement (Ruby-O) at a moderate dose, the same phospholipid-based omega-3 supplement at a higher dose, or a conventional omega-3 supplement in triglyceride form. All study products will be taken by mouth once daily with food for 24 weeks.
The main goal of the study is to evaluate changes in the Omega-3 Index, a blood test that reflects the amount of omega-3 fatty acids incorporated into red blood cell membranes. Additional goals include evaluating changes in blood lipid levels, markers of inflammation, blood sugar metabolism, body weight, blood pressure, treatment adherence, and safety.
This study is sponsored by the Fundación del Caribe para la Investigación Biomédica and is conducted in adults who are receiving stable statin therapy. Participation in the study is voluntary, and all participants may withdraw at any time.
详细描述
Mixed dyslipidemia is a metabolic condition characterized by elevated triglyceride levels and other lipid abnormalities and is associated with increased residual cardiovascular risk despite standard lipid-lowering therapy. Addressing lipid abnormalities beyond low-density lipoprotein cholesterol may help reduce this residual risk.
The Omega-3 Index is defined as the percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in erythrocyte membranes and reflects long-term omega-3 fatty acid exposure and tissue incorporation. Higher Omega-3 Index values have been associated with more favorable cardiovascular risk profiles.
The chemical form of omega-3 fatty acids influences their absorption and bioavailability. Phospholipid-bound omega-3 formulations have demonstrated more efficient intestinal absorption and cellular membrane incorporation compared with conventional triglyceride-based formulations. This study was designed to evaluate whether different dose levels of a phospholipid-based omega-3 supplement result in greater changes in the Omega-3 Index compared with a conventional triglyceride-based omega-3 supplement.
This is a randomized, double-blind, parallel-group clinical trial with three study arms. Eligible participants are adults with mixed dyslipidemia receiving stable statin therapy. Participants are randomly assigned to receive either a phospholipid-based omega-3 supplement at a moderate dose, the same supplement at a higher dose, or a conventional omega-3 supplement in triglyceride form. All study products are administered orally once daily with food for a total duration of 24 weeks.
The primary objective of the study is to compare the Omega-3 Index at week 24 among treatment groups, adjusted for baseline values. Secondary objectives include evaluation of changes in lipid parameters, inflammatory biomarkers, glucose metabolism, anthropometric measures, blood pressure, treatment adherence, and safety outcomes.
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
All study products are identical in appearance, packaging, and labeling to maintain masking of participants, investigators, care providers, and outcome assessors throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Adults aged 18 years or older.
- •Diagnosis of mixed dyslipidemia.
- •Fasting triglyceride levels between 135 and 499 mg/dL.
- •Body mass index (BMI) ≥27 kg/m².
- •High-sensitivity C-reactive protein (hs-CRP) >2 mg/L.
- •Stable statin therapy for at least 8 weeks prior to enrollment.
- •Ability and willingness to provide written informed consent.
排除标准
- •Fasting triglyceride levels ≥500 mg/dL.
- •History of a recent cardiovascular event.
- •Significant hepatic or renal disease.
- •Pregnancy or breastfeeding.
- •Known allergy or hypersensitivity to fish or seafood.
- •Use of omega-3 supplements within 8 weeks prior to randomization.
- •Participation in another interventional clinical trial within 8 weeks prior to enrollment.
研究组 & 干预措施
Ruby-O Moderate Dose
Participants receive a phospholipid-based omega-3 supplement (Ruby-O) providing approximately 995 mg of EPA+DHA daily, administered orally once daily with meals for 24 weeks.
干预措施: Phospholipid Omega-3 (Dietary Supplement)
Ruby-O High Dose
Participants receive a phospholipid-based omega-3 supplement (Ruby-O) providing approximately 1491 mg of EPA+DHA daily, administered orally once daily with meals for 24 weeks.
干预措施: Phospholipid Omega-3 (Dietary Supplement)
Conventional Omega-3
Participants receive a conventional triglyceride-based omega-3 supplement providing EPA 900 mg and DHA 600 mg daily, administered orally once daily with meals for 24 weeks.
干预措施: Triglyceride Omega-3 (Dietary Supplement)
结局指标
主要结局
Omega-3 Index (O3I)
时间窗: Week 24
The Omega-3 Index (O3I) is a continuous biochemical measure defined as the percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in erythrocyte membranes, measured by standardized erythrocyte fatty acid analysis. It is expressed as a percentage (%), with values observed in adult populations typically ranging from approximately 2% (very low levels) to 15% (very high levels), although no absolute theoretical maximum is defined. Higher Omega-3 Index values indicate a more favorable cardiovascular risk profile. The primary analysis uses the value at week 24, adjusted for baseline.
次要结局
未报告次要终点
研究者
Miguel Urina-Triana PhD
Principal Investigator
Fundación del Caribe para la Investigación Biomédica