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New Omega-3 pill could boost heart health better than standard fish oil

NCT ID NCT07394517

Disease control Sponsor: Fundación del Caribe para la Investigación Biomédica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new omega-3 supplement called Ruby-O, made from phospholipids, raises omega-3 levels in the blood more effectively than standard omega-3 supplements. About 105 adults with mixed dyslipidemia (abnormal blood fats) who are already on statin therapy will take one of three supplements daily for 24 weeks. The main goal is to measure changes in the Omega-3 Index, a marker of heart health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Phospholipid omega-3 supplement (Ruby-O) and conventional triglyceride omega-3 supplement
What this could lead to
If successful, this could show that a new form of omega-3 supplement raises omega-3 levels in the blood better than standard supplements, potentially improving heart health.
What could go wrong
This is an early-stage trial with only 105 participants, so results may not apply to everyone. The supplement may not significantly outperform the standard version, and individual results vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia, familial combined, LPL related

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mixed dyslipidemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Barranquilla, Atlántico, 080020, Colombia

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