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.
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.
Fasting triglyceride levels ≥500 mg/dL.
History of a recent cardiovascular event.
Significant hepatic or renal disease.
Pregnancy or breastfeeding.
Parallel
Phospholipid Omega-3
Dietary supplementPhospholipid-based omega-3 dietary supplement containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), administered orally once daily with meals for 24 weeks at a moderate dose level.
Phospholipid Omega-3
Dietary supplementPhospholipid-based omega-3 dietary supplement containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), administered orally once daily with meals for 24 weeks at a higher dose level.
Triglyceride Omega-3
Dietary supplementConventional triglyceride-based omega-3 dietary supplement containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), administered orally once daily with meals for 24 weeks.
Omega-3 Index (O3I)
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.
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Fundación del Caribe para la Investigación Biomédica
Lead sponsor
Naturmega
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
