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

Fundación del Caribe para la Investigación Biomédica

Status: Not yet enrolling

Conditions: Mixed Dyslipidemia

Treatments: Dietary Supplement: Phospholipid Omega-3; Dietary Supplement: Triglyceride Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT07394517

BIOS-ATLANTIS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups

Ruby-O Moderate Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Phospholipid Omega-3

Dietary Supplement: Phospholipid Omega-3

Ruby-O High Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Phospholipid Omega-3

Dietary Supplement: Phospholipid Omega-3

Conventional Omega-3

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Triglyceride Omega-3