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NOT YET RECRUITING
NCT07394517
NA

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

Sponsor: Fundación del Caribe para la Investigación Biomédica

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-03

Completion Date

2027-03

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Phospholipid Omega-3

Phospholipid-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.

DIETARY_SUPPLEMENT

Phospholipid Omega-3

Phospholipid-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.

DIETARY_SUPPLEMENT

Triglyceride Omega-3

Conventional triglyceride-based omega-3 dietary supplement containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), administered orally once daily with meals for 24 weeks.

Locations (1)

Fundación del Caribe para la Investigación Biomédica (Fundación BIOS)

Barranquilla, Atlántico, Colombia