RESOLVIN: Reducing cardiovascular inflammation with fish oil or camelina (plant) oil
RESOLving INflammation Through Diet for Health Multicenter, Prospective Randomized, Controlled and Open- Label to Examine the Impact of a Diet Enriched in Omega 3 Fatty Acids of Animal and Vegetal Origin on Circulating Lipid-driven Pro-/Antiinflammatory Balance in Subjects at Moderate to High Cardiovascular Risk.
This trial tests whether adding fish oil or camelina (plant) oil to the diet of people over 55 with moderate-to-high cardiovascular risk can lower a lipid-driven inflammation risk score.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 5 sites (Avellino, AV and 4 other locations) |
| Trial ID | NCT07331103 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged over 55 with moderate-to-high cardiovascular risk who do not have established atherosclerotic cardiovascular disease and are not already taking omega-3 supplements are the ideal candidates.
Not a fit: People with existing atherosclerotic cardiovascular disease, those on chronic n-3 PUFA therapy, individuals with fish allergy or vegan diets, significant liver dysfunction, or inability to follow the dietary plan are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the interventions could offer a simple, low-cost dietary way to reduce lipid-driven chronic inflammation and lower residual cardiovascular risk.
How similar studies have performed: Previous large trials have shown cardiovascular benefit with specific high-dose EPA formulations while results for mixed omega-3 preparations and plant-derived ALA have been mixed, making this inflammation-score approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Avellino, AV and 4 other locations
- Dr. Antonella Todesca — Avellino, Av, Italy (Not_yet_recruiting)
- Dr. Tommaso Reginato — Arese, Mi, Italy (Recruiting)
- Istituto di Ricerche Farmacologiche Mario Negri — Milan, Mi, Italy (Recruiting)
- Dr. Giosafatte Zappia — Paderno Dugnano, Mi, Italy (Not_yet_recruiting)
- Ospedale Madonna delle Grazie Matera — Matera, Mt, Italy (Not_yet_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: Marianna Cerrato, phD
- Email: marianna.cerrato@marionegri.it
- Phone: +39 023901414617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.