RESOLVIN: Reducing cardiovascular inflammation with fish oil or camelina (plant) oil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RESOLVIN randomly assigns participants to one of three 12-week dietary interventions: high-dose fish oil (rich in DHA and EPA), camelina oil (plant-derived ALA) plus vitamin E, or a non-enriched diet with vitamin E. The primary outcome is change in a combined lipid/inflammation-derived risk score measured from blood biomarkers, with secondary outcomes including biomarker profiles and participant acceptance of supplementation. Eligible participants are adults over 55 with moderate-to-high cardiovascular risk but without established atherosclerotic cardiovascular disease and not already on chronic n-3 PUFA therapy. The trial is conducted at multiple centers in Italy with centrally randomized allocation and serial biomarker measurements over the follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Casa della Salute di Cortona
  Cortona, Arezzo, Italy Recruiting
• Dr. Antonella Todesca
  Avellino, Av, Italy Recruiting
• Dr. Tommaso Reginato
  Arese, Milano, Italy Recruiting
• Dr. Giosafatte Zappia
  Paderno Dugnano, Milano, Italy Recruiting
• Dr. Lorenzo Zoccoli
  Paderno Dugnano, Milano, Italy Recruiting
• Istituto di Ricerche Farmacologiche Mario Negri
  Milan, Mi, Italy Recruiting

Study contacts

• Principal investigator: Jennifer Meessen, phD — Laboratory Clinical Research in Brain and Cardiovascular Injury Istituto di Ricerche Farmacologiche Mario Negri IRCCS
• Study coordinator: Jennifer Meessen, phD
• Email: jennifer.meessen@marionegri.it
• Phone: +39 0239014625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.