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

NCT07394517 | Not Yet Recruiting DMC

• 1 other identifier: BIOS-ATLANTIS-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mixed Dyslipidemia

Keywords

Mixed dyslipidemia; Omega -3 Index; Phospholid omega-3; Triglycerides; EPA; DHA; Dietary Suplement; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Study Arms (3)

Ruby-O Moderate Dose

EXPERIMENTAL

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.

Dietary Supplement: Phospholipid Omega-3

Ruby-O High Dose

EXPERIMENTAL

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.

Dietary Supplement: Phospholipid Omega-3

Conventional Omega-3

EXPERIMENTAL

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.

Dietary Supplement: Triglyceride Omega-3

Interventions

Phospholipid Omega-3 DIETARY_SUPPLEMENT

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.

Ruby-O High Dose

Triglyceride Omega-3 DIETARY_SUPPLEMENT

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

Conventional Omega-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación del Caribe para la Investigación Biomédica: lead
• Naturmega: collaborator

Study Sites (1)

Fundación del Caribe para la Investigación Biomédica (Fundación BIOS)

Barranquilla, Atlántico, 080020, Colombia

Location

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

Miguel A Urina, MD, PhD

CONTACT

573157219287; murina@fundacionbios.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study products are identical in appearance, packaging, and labeling to maintain masking of participants, investigators, care providers, and outcome assessors throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, parallel-group study with three arms comparing two dose levels of a phospholipid omega-3 supplement versus a conventional triglyceride omega-3 formulation.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)