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Fish oil or camelina oil: a simple diet change to fight heart inflammation?

NCT ID NCT07331103

Disease control Sponsor: Mario Negri Institute for Pharmacological Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 omega-3 fatty acids from fish oil or camelina oil can reduce inflammation and improve heart health in 324 adults over 55 at moderate to high cardiovascular risk. Participants take daily supplements for 12 weeks, and researchers measure changes in blood markers of inflammation and lipids. The goal is to find a practical dietary way to lower heart disease risk beyond standard treatments.

What this could mean

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

Active substance
Fish oil (DHA and EPA), camelina oil (ALA), and vitamin E
What this could lead to
If successful, this could show that simple dietary supplements like fish or camelina oil help control inflammation and lower heart disease risk.
What could go wrong
This is a small, early-stage study (324 people) over only 12 weeks, so results may not apply broadly. The effect on actual heart attacks or strokes is not being measured directly.

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 324 people

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

Started

Nov 2025

Expected to finish

Jun 2026

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

55 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: * Participants are subjects \>55 y old from both sexes (\>=40% women) with moderate to high cardiovascular risk (ANNEX 1: SCORE2, SCORE2-OP and SCORE2-Diabetes assessment). Exclusion Criteria: * cardiovascular disease, * established atherosclerotic vascular disease involving the coronary, peripheral, carotid, or aortic territories (identified by computerized tomography (CT) of coronary arteries, MRI, carotid or peripheral ultrasound imaging), * chronic treatment with n-3 PUFA containing products (i.e., Vazkepa), * a condition that interferes with the possibility to follow the dietary intervention, such as fish allergy or being a vegan, * significant liver dysfunction, * participation in another intervention clinical study.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hyperlipidemia Inflammation inflammatory disease

As listed by the trial registrant

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

Cardiovascualr disease Inflammation LIPIDS N-3 polyunsatured fatty acids (N-3 pufa)

How to take part

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

  1. The places running it

    5 sites. 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

  • Dr. Antonella Todesca

    NOT_YET_RECRUITING

    Avellino, AV, 83036, Italy

  • Dr. Giosafatte Zappia

    NOT_YET_RECRUITING

    Paderno Dugnano, MI, 20037, Italy

  • Dr. Tommaso Reginato

    RECRUITING

    Arese, MI, 20044, Italy

  • Istituto di Ricerche Farmacologiche Mario Negri

    RECRUITING

    Milan, MI, 20156, Italy

  • Ospedale Madonna delle Grazie Matera

    NOT_YET_RECRUITING

    Matera, MT, 75100, Italy

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