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

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

Overview

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.

Detailed description

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.

The study is conducted in accordance with ethical principles for research involving human participants and has been approved by an institutional ethics committee. Participation is voluntary, and all participants provide written informed consent prior to any study-related procedures.

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.

Primary outcome measures

• Omega-3 Index (O3I) [Time frame: Week 24]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Colombia · 1 center

• Fundación del Caribe para la Investigación Biomédica (Fundación BIOS) — Barranquilla

Publications

• Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030. PMID 15208005

Identifiers

NCT: NCT07394517 · BIOS-ATLANTIS-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗