Cardiovascular (CV) RiskRESOLvingNCT07331103
RESOLving INflammation Through Diet for Health (RESOLVIN)
A study testing Fish Oil, Camelina oil and Vitamin E in people with Cardiovascular (CV) Risk and Inflammation, run by Mario Negri Institute for Pharmacological Research at 9 sites in Italy.
Trial summary
Hyperlipidemia is the main driver of atherosclerotic cardiovascular disease (ASCVD), both through direct effects and as trigger of the chronic inflammation behind a cardiovascular health-to-disease transition. While lipid-lowering is an effective way to reduce the ASCVD risk, the residual risk remains high. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cardiovascular (CV) Risk, Inflammation, Omega 3
- What is being tested?
- Fish Oil, Camelina oil and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 9 sitesItaly
- Study dates
- 26 Nov 2025to 30 Jun 2027
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
Dr. Tommaso Reginato
Arese, Milano, 20044
Tommaso Reginato, MD, +39 0293586383, dottor.reginato@gmail.com
- Recruiting
Dr. Antonella Todesca
Avellino, AV, 83036
Antonella Todesca, MD, +390825447893, todesca2000@libero.it
- Recruiting
Casa della Salute di Cortona
Cortona, Arezzo, 52044
roberto.nasorri@gmail.com
Roberto Nasorri, md, roberto.nasorri@gmail.com
- Recruiting
Ospedale di Gubbio - Gualdo Tadino
Gubbio, PG, 06024
Deborah Cosmi, MD, deborah.cosmi@uslumbria1.it
- Not yet recruiting
Ospedale Madonna delle Grazie Matera
Matera, 75100
Francesca Cortese, MD, +39 0835253111, francesca.cortese@asmbasilicata.it
- Recruiting
Istituto di Ricerche Farmacologiche Mario Negri
Milan, MI, 20156
- Recruiting
Dr. Giosafatte Zappia
Paderno Dugnano, Milano, 20037
Giosafatte Zappia, MD, +39 0239624643, studiomedico.gzappia@gmail.com
- Recruiting
Dr. Lorenzo Zoccoli
Paderno Dugnano, Milano, 20037
Lorenzo Zoccoli, MD, lorenzozoccoli@gmail.com
- Recruiting
Amb. Popolare, Borgo Vecchio e - Amb. Popolare Zen
Palermo, Pa, 90127
Renato Costa, MD, renatopatrizio.costa@gmail.com
Franco Ingrillì, md, francoingrilli1956@gmail.com
About this study
Official title: 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.
Hyperlipidemia is the main driver of atherosclerotic cardiovascular disease (ASCVD), both through direct effects and as trigger of the chronic inflammation behind a cardiovascular health-to-disease transition. While lipid-lowering is an effective way to reduce the ASCVD risk, the residual risk remains high. In addition, a substantial proportion of ASCVD events occur in the absence of overt hyperlipidemia. Several lines of evidence ranging from experimental models to population studies and interventional clinical trials support chronic inflammation as the causal residual risk of CVD. The CVD risk-associated lipid classes contain fatty acids that can be liberated and metabolized into both inflammation-promoting as well as inflammation-resolving drivers, providing the rationale for focusing on this balance in the present project. Above all, the omega-3 fatty acid class can resolve inflammation but the potential impact is currently largely underestimated in CVD preventive recommendations. As cardiovascular preventive measures ease the burden placed on the individual, population, and on the health care system, it is critical to raise public awareness for chronic inflammation as a causative and modifiable cardiovascular risk factor and to provide tools for how to control and monitor it. As an alternative to marine sources, principally eicosapentaenoic acid (EPA) and less docosahexaenoic acid (DHA) can be endogenously produced from alpha-linolenic acid (ALA) found in plant oils. Secondarily the possibility to increase the consumption of vegetable oil may possibly decrease the environmental impacts of an intensive fishing and consecutive marine system imbalance. The overarching objective of CARE-IN-HEALTH is to assess if PUFAs may contribute to the resolution of the chronic lipid-driven/-regulated vascular inflammation in order to develop and test, in a real-life setting, tools for use in health care and by citizens to stay healthy by an adequate resolution of the chronic inflammation. The primary objective of the present study is to compare the effect on a lipid/inflammation-derived risk score of diets supplemented with polyunsaturated fatty acids (PUFA) of animal or vegetal origin with a nonenriched diet. The secondary objectives are a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipid, inflammatory glycemic profile based on serial measurements of circulating biomarkers by means of PUFA supplementation. The inclusion criteria are: Eligible participants will be at moderate to high SCORE2, SCORE2-OP and SCORE2-Diabetes risk level.
Non-eligible subjects will be those with:
- 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) or fibrates,
- 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. Eligible participants will undergo a clinical visit when also a blood sample will be taken at baseline and at 12 weeks follow-up. The main analysis will be performed according to a per protocol approach, therefore only participants compliant with study treatments will be included in the analysis. Primary objective: to compare the effect on a lipid/inflammation-derived risk score, based on circulating molecules, of diets enriched with PUFA of animal or vegetal origin with a non-enriched diet. Secondary objectives: a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipidic/glycemic inflammatory profile. All 324 participants enrolled in the trial will have blood samples taken twice (at baseline and 12 weeks),
Read the detailed description
This study aims to identify a blueprint for how to control lipid-driven chronic inflammation as well as tools to support the deployment of innovative personalized prevention of ASCVD by simple, easy dietary changes. In particular the primary endpoint is to compare the effect on a lipid/inflammation-derived risk score, of diets with supplementation of PUFA of animal or of vegetal origin with a non-enriched diet.
The secondary end points are: a) to assess the acceptance of supplementation of diet with animalderived or plant-derived PUFAs; b) to improve, by means of PUFA dietary supplementation, circulating lipidic/glycemic inflammatory profile based on serial measurements of circulating biomarkers. All subjects meeting inclusion/exclusion criteria will be centrally randomized by a web-based system to one of the three interventions:
- supplementation with 4 grams of fish oil (containing 2262.5 mg DHA plus 1739.1 mg EPA, although a 10% variability due to the natural origin of the product must be considered), 2) diet enriched with 10 grams ALA of vegetable origin (Camelina Sativa Oil) + Vitamin E 24 mg, 3) regular non-enriched diet + Vitamin E 24 mg. Participants in RESOLVIN study will receive study agents from enrolment until 12 weeks follow-up.
The daily intake of EPA will be 1739 mg in participants assigned to fish oil, approximately 1500 mg for those assigned to 30 ml of camelina oil. The daily volume of camelina oil cannot be increased further without jeopardizing participant's compliance. The addition of vitamin E is aimed at supplementing the same amount of this vitamin to participants. The differential supplementation with vitamin E is requested by the different content of the vitamin in fish oil vs camelina oil. Both the fish oil and the camelina oil will be administered before food ingestion.
The study oils are ready to be ingested. Storage and dispensing of the study products will be done by the site pharmacists or by the responsible physician. The study oil ingestion will begin at randomization and will continue for 12 weeks. The addition of vitamin E is aimed at supplementing the same amount of this vitamin to participants assigned to camelina oil and controls. Vitamin E will be administered as solution, corresponding approx. to a daily dose of 24 mg.
At baseline, a blood sample for fatty acid analysis will be taken, demographic, clinical and treatment data will be collected, heart rate and blood pressure and waist circumference will be measured. At 12 weeks follow-up, clinical information about tolerance of diets enriched by PUFAs and any clinical event will be collected. Heart rate, blood pressure and waist circumference will be measured; blood will be sampled at baseline and 12 weeks to be processed stored and then shipped to the central biobank. All participants will be asking to complete a 15-item dietary assessment questionnaire at baseline and 12 weeks follow-up. Central randomization will be performed in a 1:1:1 ratio. The following information will be required:
- center/GP code, participant initials, date of birth, sex.
- inclusion and exclusion criteria.
- signed and dated informed consent. A participant will be considered randomized when the randomization system will assign the participants identification number according to a pre-established randomization list. Randomization will be stratified by Centre/GP.
- Conditions
- Cardiovascular (CV) Risk, Inflammation, Omega 3
- Being tested
- Fish Oil, Camelina oil, Vitamin E
- Keywords
- lipids, atheroscleris, cardiovascular disease
- Medical subject headings
- Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
2262.5 mg DHA plus 1739.1 mh EPA
Camelina oilDietary supplement
10g/day of ALA for a total volume of 30 mL/day
Vitamin EDietary supplement
a dose of 24 mg for the control group
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | A total daily volume of 23.19 mL/day of fish oil. Receives: Dietary Supplement: Fish Oil |
| Camelina Sativa Oil | Active comparator | a total volume of 30 mL/day + Vitamin E 24 mg. Receives: Dietary Supplement: Camelina oil |
| Control | Active comparator | regular non-enriched diet + Vitamin E 24 mg Receives: Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect on a lipidomic/inflammation- derived risk score based on plasma biomarkers
to compare the effect on a lipid/inflammation-derived risk score moderate= 50-69 years: 5 to 10%; >70 years: 7.5 to <15%; high=50-69 years: >10%; 70 years >15%, based on circulating molecules, of diets enriched with PUFA of animal or vegetal origin with a non-enriched diet.
Measured: up to 12 weeks
Primary objective
The primary endpoint is to compare the effect on a lipidomic/inflammation-derived risk score based on plasma biomarkers, of diets with supplementation with PUFA of animal or vegetal origin with a non-enriched diet.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start26 Nov 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective randomized, controlled and open- label
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Meessen, phD, Principal investigator, Laboratory Clinical Research in Brain and Cardiovascular Injury Istituto di Ricerche Farmacologiche Mario Negri IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331103
- Sponsor's protocol ID
- HORIZON-HLTH-2022-STAYHLTH-02
- Other IDs
- HORIZON-HLTH-2022- STAYHLTH-02
- Acronym
- RESOLving
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
PubMed 10465168Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017 Sep 21;377(12):1119-1131. doi: 10.1056/NEJMoa1707914. Epub 2017 Aug 27.
PubMed 28845751Tunon J, Badimon L, Bochaton-Piallat ML, Cariou B, Daemen MJ, Egido J, Evans PC, Hoefer IE, Ketelhuth DFJ, Lutgens E, Matter CM, Monaco C, Steffens S, Stroes E, Vindis C, Weber C, Back M. Identifying the anti-inflammatory response to lipid lowering therapy: a position paper from the working group on atherosclerosis and vascular biology of the European Society of Cardiology. Cardiovasc Res. 2019 Jan 1;115(1):10-19. doi: 10.1093/cvr/cvy293.
PubMed 30534957Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905Back M, Yurdagul A Jr, Tabas I, Oorni K, Kovanen PT. Inflammation and its resolution in atherosclerosis: mediators and therapeutic opportunities. Nat Rev Cardiol. 2019 Jul;16(7):389-406. doi: 10.1038/s41569-019-0169-2.
PubMed 30846875
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07331103
- Acronym / sponsor ID
- RESOLving / HORIZON-HLTH-2022-STAYHLTH-02
- Conditions
- Cardiovascular (CV) Risk, Inflammation, Omega 3
- Keywords
- lipids, atheroscleris, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jan 2026 (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.
Hyperlipidemia is the main driver of atherosclerotic cardiovascular disease (ASCVD), both through direct effects and as trigger of the chronic inflammation behind a cardiovascular health-to-disease transition. While lipid-lowering is an effective way to reduce the ASCVD risk, the residual risk remains high. In addition, a substantial proportion of ASCVD events occur in the absence of overt hyperlipidemia. Several lines of evidence ranging from experimental models to population studies and interventional clinical trials support chronic inflammation as the causal residual risk of CVD. The CVD risk-associated lipid classes contain fatty acids that can be liberated and metabolized into both inflammation-promoting as well as inflammation-resolving drivers, providing the rationale for focusing on this balance in the present project. Above all, the omega-3 fatty acid class can resolve inflammation but the potential impact is currently largely underestimated in CVD preventive recommendations. As cardiovascular preventive measures ease the burden placed on the individual, population, and on the health care system, it is critical to raise public awareness for chronic inflammation as a causative and modifiable cardiovascular risk factor and to provide tools for how to control and monitor it. As an alternative to marine sources, principally eicosapentaenoic acid (EPA) and less docosahexaenoic acid (DHA) can be endogenously produced from alpha-linolenic acid (ALA) found in plant oils. Secondarily the possibility to increase the consumption of vegetable oil may possibly decrease the environmental impacts of an intensive fishing and consecutive marine system imbalance. The overarching objective of CARE-IN-HEALTH is to assess if PUFAs may contribute to the resolution of the chronic lipid-driven/-regulated vascular inflammation in order to develop and test, in a real-life setting, tools for use in health care and by citizens to stay healthy by an adequate resolution of the chronic inflammation. The primary objective of the present study is to compare the effect on a lipid/inflammation-derived risk score of diets supplemented with polyunsaturated fatty acids (PUFA) of animal or vegetal origin with a nonenriched diet. The secondary objectives are a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipid, inflammatory glycemic profile based on serial measurements of circulating biomarkers by means of PUFA supplementation. The inclusion criteria are: Eligible participants will be at moderate to high SCORE2, SCORE2-OP and SCORE2-Diabetes risk level.
Non-eligible subjects will be those with:
- 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) or fibrates,
- 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. Eligible participants will undergo a clinical visit when also a blood sample will be taken at baseline and at 12 weeks follow-up. The main analysis will be performed according to a per protocol approach, therefore only participants compliant with study treatments will be included in the analysis. Primary objective: to compare the effect on a lipid/inflammation-derived risk score, based on circulating molecules, of diets enriched with PUFA of animal or vegetal origin with a non-enriched diet. Secondary objectives: a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipidic/glycemic inflammatory profile. All 324 participants enrolled in the trial will have blood samples taken twice (at baseline and 12 weeks),
Detailed description
This study aims to identify a blueprint for how to control lipid-driven chronic inflammation as well as tools to support the deployment of innovative personalized prevention of ASCVD by simple, easy dietary changes. In particular the primary endpoint is to compare the effect on a lipid/inflammation-derived risk score, of diets with supplementation of PUFA of animal or of vegetal origin with a non-enriched diet.
The secondary end points are: a) to assess the acceptance of supplementation of diet with animalderived or plant-derived PUFAs; b) to improve, by means of PUFA dietary supplementation, circulating lipidic/glycemic inflammatory profile based on serial measurements of circulating biomarkers. All subjects meeting inclusion/exclusion criteria will be centrally randomized by a web-based system to one of the three interventions:
- supplementation with 4 grams of fish oil (containing 2262.5 mg DHA plus 1739.1 mg EPA, although a 10% variability due to the natural origin of the product must be considered), 2) diet enriched with 10 grams ALA of vegetable origin (Camelina Sativa Oil) + Vitamin E 24 mg, 3) regular non-enriched diet + Vitamin E 24 mg. Participants in RESOLVIN study will receive study agents from enrolment until 12 weeks follow-up.
The daily intake of EPA will be 1739 mg in participants assigned to fish oil, approximately 1500 mg for those assigned to 30 ml of camelina oil. The daily volume of camelina oil cannot be increased further without jeopardizing participant's compliance. The addition of vitamin E is aimed at supplementing the same amount of this vitamin to participants. The differential supplementation with vitamin E is requested by the different content of the vitamin in fish oil vs camelina oil. Both the fish oil and the camelina oil will be administered before food ingestion.
The study oils are ready to be ingested. Storage and dispensing of the study products will be done by the site pharmacists or by the responsible physician. The study oil ingestion will begin at randomization and will continue for 12 weeks. The addition of vitamin E is aimed at supplementing the same amount of this vitamin to participants assigned to camelina oil and controls. Vitamin E will be administered as solution, corresponding approx. to a daily dose of 24 mg.
At baseline, a blood sample for fatty acid analysis will be taken, demographic, clinical and treatment data will be collected, heart rate and blood pressure and waist circumference will be measured. At 12 weeks follow-up, clinical information about tolerance of diets enriched by PUFAs and any clinical event will be collected. Heart rate, blood pressure and waist circumference will be measured; blood will be sampled at baseline and 12 weeks to be processed stored and then shipped to the central biobank. All participants will be asking to complete a 15-item dietary assessment questionnaire at baseline and 12 weeks follow-up. Central randomization will be performed in a 1:1:1 ratio. The following information will be required:
- center/GP code, participant initials, date of birth, sex.
- inclusion and exclusion criteria.
- signed and dated informed consent. A participant will be considered randomized when the randomization system will assign the participants identification number according to a pre-established randomization list. Randomization will be stratified by Centre/GP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, prospective randomized, controlled and open- label
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Fish OilA total daily volume of 23.19 mL/day of fish oil. |
| Camelina Sativa Oil | Active comparator | Dietary Supplement: Camelina oila total volume of 30 mL/day + Vitamin E 24 mg. |
| Control | Active comparator | Dietary Supplement: Vitamin Eregular non-enriched diet + Vitamin E 24 mg |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Fish Oil2262.5 mg DHA plus 1739.1 mh EPA | Dietary supplement | Fish oil |
| Camelina oil10g/day of ALA for a total volume of 30 mL/day | Dietary supplement | Camelina Sativa Oil |
| Vitamin Ea dose of 24 mg for the control group | Dietary supplement | Control |
Primary outcome
the effect on a lipidomic/inflammation- derived risk score based on plasma biomarkers
Time frame: up to 12 weeks
to compare the effect on a lipid/inflammation-derived risk score moderate= 50-69 years: 5 to 10%; >70 years: 7.5 to <15%; high=50-69 years: >10%; 70 years >15%, based on circulating molecules, of diets enriched with PUFA of animal or vegetal origin with a non-enriched diet.
Primary objective
Time frame: 18 months
The primary endpoint is to compare the effect on a lipidomic/inflammation-derived risk score based on plasma biomarkers, of diets with supplementation with PUFA of animal or vegetal origin with a non-enriched diet.
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 9 Oct 2026.
- Background: PubMed 10465168Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
- Background: PubMed 28845751Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017 Sep 21;377(12):1119-1131. doi: 10.1056/NEJMoa1707914. Epub 2017 Aug 27.
- Background: PubMed 30534957Tunon J, Badimon L, Bochaton-Piallat ML, Cariou B, Daemen MJ, Egido J, Evans PC, Hoefer IE, Ketelhuth DFJ, Lutgens E, Matter CM, Monaco C, Steffens S, Stroes E, Vindis C, Weber C, Back M. Identifying the anti-inflammatory response to lipid lowering therapy: a position paper from the working group on atherosclerosis and vascular biology of the European Society of Cardiology. Cardiovasc Res. 2019 Jan 1;115(1):10-19. doi: 10.1093/cvr/cvy293.
- Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Background: PubMed 30846875Back M, Yurdagul A Jr, Tabas I, Oorni K, Kovanen PT. Inflammation and its resolution in atherosclerosis: mediators and therapeutic opportunities. Nat Rev Cardiol. 2019 Jul;16(7):389-406. doi: 10.1038/s41569-019-0169-2.
- Individual participant dataSharing planned: No
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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.
Jennifer Meessen, phD principal investigator
Laboratory Clinical Research in Brain and Cardiovascular Injury Istituto di Ricerche Farmacologiche Mario Negri IRCCS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil, Camelina oil and Vitamin E in people with Cardiovascular (CV) Risk and Inflammation, run by Mario Negri Institute for Pharmacological Research at 9 sites in Italy.
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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. 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?
Contact Jennifer Meessen, phD (+39 0239014625, jennifer.meessen@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect on a lipidomic/inflammation- derived risk score based on plasma biomarkers (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT07331103, which also lists 5 linked publications.
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 9 Oct 2026.