HypertriglyceridemiaOMEGA-PHYTNCT06749028

Evaluation of the Efficacy of Phospholipid-Bound Omega-3 Versus Omega-3 Alone in Patients With Hypertriglyceridemia: A Randomized Clinical Trial

A study testing Intervention Arm: Omega-3 + Phospholipids. and Comparator Arm: Omega-3 alone. in people with Hypertriglyceridemia, run by Fundación del Caribe para la Investigación Biomédica at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertriglyceridemia
What is being tested?: Intervention Arm: Omega-3 + Phospholipids. and Comparator Arm: Omega-3 alone.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteColombia
Study dates: 17 Dec 2024to 31 Aug 2025
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged ≥18 to 65 years.
Triglyceride levels ≥ 150 mg/dL and ≤ 500 mg/dL.
Signed informed consent.

Who cannot join

Use of omega-3 supplements in the last 3 months.
Use of any lipid-lowering medication.
Known allergy to the components of the treatment.
Uncontrolled chronic diseases (e.g., renal failure, liver disease).
Any type of cancer.
Undergoing treatment for HIV.
Pregnancy or breastfeeding.
Use of substances or prescribed medications that may increase triglyceride levels (e.g., estrogens, atypical antipsychotics, etc.). -

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Fundacion del Caribe para la Investigación Biomedica
Barranquilla, Atlántico, 080020

Other trials in Colombia

About this study

Hypertriglyceridemia is a significant risk factor for cardiovascular diseases. Omega-3 fatty acids have been shown to reduce triglyceride levels, and their combination with phospholipids could offer additional benefits in improving lipid profiles and inflammatory markers. This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence on the benefits of this combination in improving lipid profiles and reducing inflammation, which could have a significant impact on clinical practices and future dietary recommendations.

Read the detailed description

This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence of the benefits of this combination in improving lipid profiles and reducing inflammation, which could significantly impact clinical practices and future dietary recommendations.

Conditions: Hypertriglyceridemia
Being tested: Intervention Arm: Omega-3 + Phospholipids., Comparator Arm: Omega-3 alone.
Keywords: hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3
Medical subject headings: Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention Arm: Omega-3 + Phospholipids.Dietary supplement
Intervention Arm: Omega-3 + Phospholipids.
Comparator Arm: Omega-3 alone.Dietary supplement
Comparator Arm: Omega-3 alone.

Study groups in NCT06749028
Study group	Role	What they receive
Group B: Comparator Arm: Omega-3 alone.	Active comparator	Comparator Arm: Omega-3 alone Receives: Dietary Supplement: Comparator Arm: Omega-3 alone.
Group A: Intervention Arm: Omega-3 + Phospholipids.	Experimental	Intervention Arm: Omega-3 + Phospholipids. Receives: Dietary Supplement: Intervention Arm: Omega-3 + Phospholipids.

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in Triglyceride Levels
Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.
Measured: 12 weeks

Secondary outcomes (3)

Reduction in Inflammatory Markers
Assess changes in levels of inflammatory markers such as High Sensivity CRP (C-reactive protein) and IL-6 (interleukin-6) from baseline to 12 weeks.
Measured: 12 weeks
Improvement in HOMA-IR Index
Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks.
Measured: 12 weeks
Improvement in Omega Index
Assess changes in the Omega Index (percentage of omega-3 fatty acids in red blood cell membranes) from baseline to 12 weeks.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 202431 Aug 2025

First posted27 Dec 2024
Study start17 Dec 2024
Primary completion20 May 2025
Study completion31 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertriglyceridemiaStudies 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: PICOT * Population:Adult patients ≥ 18 years old diagnosed with hypertriglyceridemia, defined as triglycerides \>150 mg/dL. * Intervention: Omega-3 + phospholipids. * Comparator: Omega-3. * Outcome: Reduction in triglyceride levels and inflammatory markers, improvement in HOMA-IR index, and Omega Index. * Time:12 weeks.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 44 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06749028
Sponsor's protocol ID: 202401OMEGA-PHYT
Acronym: OMEGA-PHYT
Status last verified: Jul 2025
First submitted: 19 Dec 2024
Last updated: 17 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 1. Purpose of Data Sharing: Explain why the personal data will be shared, such as to foster collaboration on additional research, validate results, or conduct broader analyses. 2. Types of Data to be Shared: Describe the types of personal or sensitive data that will be shared, ensuring that only the necessary data for research will be provided. 3. Confidentiality and Security Measures: Detail how personal data will be protected to ensure the privacy and confidentiality of participants. This could include anonymizing or pseudonymizing the data, using secure platforms for data exchange, and complying with legal regulations such as the General Data Protection Regulation (GDPR). 4. Requirements for Researchers Receiving the Data: Specify the requirements for researchers receiving the data, such as signing confidentiality agreements and committing to use the data solely for the agre

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
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All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Phospholipid-Bound Omega-3 Versus Omega-3 Alone in Patients With Hypertriglyceridemia: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06749028
Acronym / sponsor ID: OMEGA-PHYT / 202401OMEGA-PHYT
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 44 participants (estimated)
Lead sponsor: Fundación del Caribe para la Investigación BiomédicaUniversity, hospital or other
Collaborators: Naturmega
Study start: 17 Dec 2024 (actual)
Primary completion: 20 May 2025 (actual)
Study completion: 31 Aug 2025 (estimated)
First posted: 27 Dec 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: PICOT * Population:Adult patients ≥ 18 years old diagnosed with hypertriglyceridemia, defined as triglycerides >150 mg/dL. * Intervention: Omega-3 + phospholipids. * Comparator: Omega-3. * Outcome: Reduction in triglyceride levels and inflammatory markers, improvement in HOMA-IR index, and Omega Index. * Time:12 weeks.

Arm	Type	Receives
Group B: Comparator Arm: Omega-3 alone.	Active comparator	Dietary Supplement: Comparator Arm: Omega-3 alone.Comparator Arm: Omega-3 alone
Group A: Intervention Arm: Omega-3 + Phospholipids.	Experimental	Dietary Supplement: Intervention Arm: Omega-3 + Phospholipids.Intervention Arm: Omega-3 + Phospholipids.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients aged ≥18 to 65 years.
Triglyceride levels ≥ 150 mg/dL and ≤ 500 mg/dL.
Signed informed consent.

Key exclusion criteria (8 listed)

Use of omega-3 supplements in the last 3 months.
Use of any lipid-lowering medication.
Known allergy to the components of the treatment.
Uncontrolled chronic diseases (e.g., renal failure, liver disease).
Any type of cancer.

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
Intervention Arm: Omega-3 + Phospholipids.Intervention Arm: Omega-3 + Phospholipids.	Dietary supplement	Group A: Intervention Arm: Omega-3 + Phospholipids.
Comparator Arm: Omega-3 alone.Comparator Arm: Omega-3 alone.	Dietary supplement	Group B: Comparator Arm: Omega-3 alone.

Primary outcome

Reduction in Triglyceride Levels
Time frame: 12 weeks
Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.

3 secondary outcomes

Reduction in Inflammatory Markers
Time frame: 12 weeks
Improvement in HOMA-IR Index
Time frame: 12 weeks
Improvement in Omega Index
Time frame: 12 weeks

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 17 Jul 2025.
Individual participant dataSharing planned: Yes. 1. Purpose of Data Sharing: Explain why the personal data will be shared, such as to foster collaboration on additional research, validate results, or conduct broader analyses. 2. Types of Data to be Shared: Describe the types of personal or sensitive data that will be shared, ensuring that only the necessary data for research will be provided. 3. Confidentiality and Security Measures: Detail how personal data will be protected to ensure the privacy and confidentiality of participants. This could include anonymizing or pseudonymizing the data, using secure platforms for data exchange, and complying with legal regulations such as the General Data Protection Regulation (GDPR). 4. Requirements for Researchers Receiving the Data: Specify the requirements for researchers receiving the data, such as signing confidentiality agreements and committing to use the data solely for the agre

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

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. This study is not recruiting at the moment.

Miguel A Urina, PhD principal investigator

Fundacion del Caribe para la investigación Biomedica

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Triglyceride Levels (time frame: 12 weeks). 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 NCT06749028.

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 17 Jul 2025.