Mixed DyslipidemiaATLANTISNCT07394517
ATLANTIS Trial: Phospholipid Omega-3 Versus Conventional Omega-3
A study testing Phospholipid Omega-3 and Triglyceride Omega-3 in people with Mixed Dyslipidemia, run by Fundación del Caribe para la Investigación Biomédica at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- Phospholipid Omega-3 and Triglyceride Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Fundación del Caribe para la Investigación Biomédica (Fundación BIOS)
Barranquilla, Atlántico, 080020
Miguel A Urina Triana, MD, PhD, Colombia, murina@fundacionbios.org
Miguel A Urina-Triana, MD, PhD
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Mixed Dyslipidemia
- Being tested
- Phospholipid Omega-3, Triglyceride Omega-3
- Keywords
- Mixed dyslipidemia, Omega -3 Index, Phospholid omega-3, Triglycerides, EPA, DHA, Dietary Suplement, Cardiovascular Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phospholipid Omega-3Dietary 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.
Phospholipid Omega-3Dietary 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 higher dose level.
Triglyceride Omega-3Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Triglyceride Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación del Caribe para la Investigación Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Naturmega
- Responsible party
- Principal investigator, Miguel Urina-Triana PhD, Fundación del Caribe para la Investigación Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394517
- Sponsor's protocol ID
- BIOS-ATLANTIS-01
- Acronym
- ATLANTIS
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study does not include a formal data-sharing plan and to protect participant privacy and confidentiality, in accordance with the informed consent and applicable data protection regulations.
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.
PubMed 15208005
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07394517
- Acronym / sponsor ID
- ATLANTIS / BIOS-ATLANTIS-01
- Conditions
- Mixed Dyslipidemia
- Keywords
- Mixed dyslipidemia, Omega -3 Index, Phospholid omega-3, Triglycerides, EPA, DHA, Dietary Suplement, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fundación del Caribe para la Investigación BiomédicaUniversity, hospital or other
- Collaborators
- Naturmega
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ruby-O Moderate Dose | Experimental | Dietary Supplement: Phospholipid Omega-3Participants 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. |
| Ruby-O High Dose | Experimental | Dietary Supplement: Phospholipid Omega-3Participants 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. |
| Conventional Omega-3 | Experimental | Dietary Supplement: Triglyceride Omega-3Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phospholipid Omega-3Phospholipid-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 | Ruby-O High Dose |
| Phospholipid Omega-3Phospholipid-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 | Ruby-O Moderate Dose |
| Triglyceride Omega-3Conventional triglyceride-based omega-3 dietary supplement containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), administered orally once daily with meals for 24 weeks. | Dietary supplement | Conventional Omega-3 |
Primary outcome
Omega-3 Index (O3I)
Time frame: Week 24
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 15208005Harris 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study does not include a formal data-sharing plan and to protect participant privacy and confidentiality, in accordance with the informed consent and applicable data protection regulations.
Related trials for Mixed Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
RecruitingPhase 1/2
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Hyperlipidemia; Mixed
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingObservational study
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemiia, Mixed Dyslipidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phospholipid Omega-3 and Triglyceride Omega-3 in people with Mixed Dyslipidemia, run by Fundación del Caribe para la Investigación Biomédica at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel A Urina, MD, PhD (573157219287, murina@fundacionbios.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 Index (O3I) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.