Clinical Trial

ATLANTIS Trial: Phospholipid Omega-3 Versus Conventional Omega-3

Study acronym: ATLANTIS
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-30.
Trial Details
NCT Number NCT07394517
Lead Sponsor Fundación del Caribe para la Investigación Biomédica
Collaborators: Naturmega
Conditions Mixed Dyslipidemia
Enrollment 105 participants
Start Date 2026-03
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-10