HypertensionSPIN-VANCT07038252
The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients
A study testing Oral SPM-enriched marine oil (LIPINOVA) in people with Hypertension and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Oral SPM-enriched marine oil (LIPINOVA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2025to 26 Dec 2027
- Phase
- Interventional
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years,.
- Hypertension controlled under pharmacological or non-pharmacological treatment, defined as office BP< 140/90 mmHg at the Inclusion visit,
- BMI > 30 kg/m²,
- Stable antihypertensive treatment one month before inclusion (V1),
- Signed informed consent,
- Social security affiliation.
Who cannot join
- Secondary hypertension on the basis of medical history,
- History of stroke in the previous 6 months on the basis of medical history,
- Myocardial infarction in the previous 6 months on the basis of medical history,
- Severe hepatic insufficiency on the basis of medical history,
- Chronic kidney disease (DFG < 30 ml/min 1.73 according to MDRD method),
- Pregnancy or breast feeding,
Show all 17Show fewer
- Regular treatment with NO-donors or phosphodiesterase inhibitors,
- Inability to comply with protocol requirements,
- Patient under tutorship or / guardianship or/ safeguard of justice, and incapable to give informed consent,
- Patient on AME (state medical aid),
- Participation in another interventional study involving human participants ,
- Allergy to the ultrasound gel,
- Hypersensitivity , allergy, or idiosyncratic reaction to omega-3 acids, fish or soya allergies.
- Chronic inflammatory diseases, on the basis of medical history,
- Chronic anti-inflammatory treatment administered within the past month preceding the Inclusion visit,
- Any supplementation with omega-3 or omega-6 polyunsaturated fatty acids within the past month,
- Life expectancy less than one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pharmacologie - UF Pharmacologie Clinique
Paris
Rosa Maria BRUNO, +33156093991, rosamaria.bruno@aphp.fr
Rosa Maria BRUNO
About this study
Cardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Lifestyle and dietary measures, as well as pharmacological treatments, can help correct these risk factors.
However, several studies have shown that even with optimal treatment, individuals at high risk still face a residual cardiovascular risk. This phenomenon is primarily attributed to the development of vascular lesions, meaning damage within the blood vessels. These lesions are largely due to inflammation, an activated immune state that is more pronounced in overweight individuals and significantly contributes to vascular damage, potentially shortening the lifespan of those with cardiovascular disease.
Read more
Although anti-inflammatory therapies have proven effective in reducing this risk, they may interfere with tissue repair and the immune system. For this reason, it is essential to identify strategies that promote the resolution of inflammation without compromising these vital processes.
Specialized pro-resolving mediators (SPMs) are compounds derived from omega-3 and omega-6 polyunsaturated fatty acids, which are naturally found in various foods such as fish. These mediators help limit the infiltration of inflammatory cells and initiate the repair of damaged tissues. This type of dietary supplement is already available over the counter, but its health benefits have not been extensively studied. Experimental animal studies have shown that restoring inflammation resolution through SPMs can prevent-or even reverse-cardiovascular damage and inflammation by directly acting on vascular cells and modulating the immune system. However, human data on the role of SPMs and inflammation resolution in vascular disease remain very limited.
The investigators hypothesize that in individuals at high cardiovascular risk (due to obesity and hypertension), increasing circulating levels of SPMs through oral supplementation (as a dietary supplement) would improve vascular function, metabolic profile, and inflammatory and immune cell responses. In doing so, this may help reduce the residual risk of cardiovascular disease.
The objective of this research is to assess whether a supplement enriched with SPMs can facilitate the resolution of inflammation, which is essential for restoring vascular function and thereby supporting the body's natural tissue repair mechanisms.
To address the research question, the study plans to include 60 individuals with obesity and hypertension, all presenting a high cardiovascular risk, recruited from healthcare facilities located in France.
This research is publicly funded by the French National Research Agency (Agence Nationale de la Recherche) through the European research project RESPIN-VAR, co-funded by ERA4Health and the European Union.
- Conditions
- Hypertension, Obesity
- Being tested
- Oral SPM-enriched marine oil (LIPINOVA), Placebo
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral SPM-enriched marine oil (LIPINOVA)Dietary supplement
Also called SPM-enriched marine oil, Omega-3 free fatty acids with SPM precursors, Specialized pro-resolving mediator supplement
LIPINOVA is an oral dietary supplement provided by Solutex, consisting of marine oil enriched in specialized pro-resolving mediator (SPM) precursors. Each daily dose (3 g/day) includes 1500 mg of omega-3 free fatty acids and a minimum of 520 mcg of SPM precursors (17-HDHA, 18-HEPE, 14-HDHA). The supplement is administered orally in 6 softgel capsules per day (3 after breakfast, 3 after dinner) over 12 weeks. It is used to investigate its effect on vascular function and inflammation in patients with obesity-related hypertension. The product is over-the-counter and commonly available in the EU, including France.
PlaceboDietary supplement
Also called Olive oil capsules, Placebo SPM supplement
Placebo capsules provided by Solutex, identical in appearance to LIPINOVA, contain refined olive oil with no active omega-3 fatty acids or SPM precursors. The placebo is administered orally in 6 softgel capsules per day (3 after breakfast, 3 after dinner) for 12 weeks, following a randomized, double-blind, crossover design. It serves as a control to evaluate the effects of SPM-enriched marine oil on vascular and inflammatory parameters in patients with obesity-related hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: active product is Oral SPM-enriched marine oil | Experimental | Active treatment product is Oral SPM-enriched marine oil (3 gr/day) 3 capsules after breakfast and 3 capsules after dinner, provided by Solutex. Receives: Dietary Supplement: Oral SPM-enriched marine oil (LIPINOVA) |
| Control arm :Placebo (olive oil) | Placebo comparator | Placebo (olive oil) will be provided by Solutex too and will have the same appearance (3 capsules after breakfast and 3 capsules after dinner) as active Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation (FMD)
Conduit-artery endothelial function measured by flow-mediated dilation (FMD) after 12 week-intervention with oral SPM supplementation or placebo.
Measured: FMD will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 16 (after a wash-out period of 2 weeks ± 2 days), Week 28 (after a second administration period of 12 weeks ± 2 days)
Secondary outcomes (14)
Shear rate area under the curve (SR-AUC)
SR-AUC measured as the integral of brachial artery shear rate (flow velocity/diameter*0,8) following post-ischemic reactive hyperemia induced by 5-min forearm cuff occlusion during FMD test
Measured: These parameters will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 16 (after a wash-out period of 2 weeks ± 2 days), Week 28 (after a second administration period of 12 weeks ± 2 days)
Difference after 12 -week- intervention with oral SPM supplementation or placebo in arterial stiffness
Arterial stiffness measured by cfPWV, office brachial and central BP and central hemodynamics measured by Sphygmocor CVMS.
Measured: These parameters will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 16 (after a wash-out period of 2 weeks ± 2 days), Week 28 (after a second administration period of 12 weeks ± 2 days)
Change from initiation to the end of the 12 -week- intervention in endothelial injury
This outcome assesses endothelial injury by measuring a panel of biological markers that together reflect vascular endothelial function and inflammatory status. The selecting markers includes: panel of 15 markers including sICAM, sVCAM, eSelectin, vWF, based on ELISA (in house assay), electrochemiluminescence (V-PLEX, MesoScale Discoveries) and LuminexTM technologies.) and inflammatory cytokines (16 different cytokines including CRP, SAA, IL-6, IL-8, TNF-a)
Measured: These parameters will be measured at Week 0 (baseline), Week 12, Week 16, Week 28.
Change from initiation to the end of the 12 -week- intervention immune cell profile
A panel of 12 soluble immune checkpoints as potential novel actors in cardiovascular disease will be quantified including sCD25 (IL-2Ra), s4-1BB, sCD27, sCD86 (B7.2), TGF-β1 (free active form), sCTLA-4, and sGalectin-9, among others. PBMCs will be assayed for their activation capabilities by means of multiparametric intracellular spectral flow cytometry in the presence of a polyclonal stimulation.
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Insulin sensitivity
Insulin sensitivity will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and insulin levels. This outcome evaluates metabolic response to the intervention.
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Change in Body Fat Mass
Body fat mass will be measured using a validated smart scale based on bioelectrical impedance. This outcome assesses changes in body composition during the intervention period.
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Change in Lipid profile
Serum total cholesterol, HDL cholesterol, and triglycerides concentration will be measured as a marker of lipid metabolism.
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Safety assessement by Liver function markers
Description : Liver function markers are AST, ALT, gammaGT
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Safety assessement by Renal function markers
Renal function will be evaluated through a composite of serum creatinine, serum uric acid, and urinalysis parameters (albuminuria/creatinuria ratio).
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Safety assessement by Coagulation markers
Coagulation function will be evaluated through a composite of prothrombin time and activated partial thromboplastin time.
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
SPM levels
SPM levels
Measured: These parameters will be measured at Week 0, Week12, Week16, Week28
Questionnaires about perceptions and expectations about oral supplements for cardiovascular disease prevention
Change in Perceptions and Expectations Regarding Oral Supplements for Cardiovascular Disease Prevention
Participants will complete a questionnaire assessing their perceptions and expectations about the use of oral supplements forcardiovascular disease prevention.
Measured: Week 0 and Week 28
Health Literacy Questionnaire
Participants health literacy will be evaluated at the end of the intervention using a validated health literacy questionnaire. The objective is to assess their ability to access, understand, and use health-related information for decision-making.
Measured: Week 28
Questionnaire about vascular ageing awareness
Questionnaire about vascular ageing awareness
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start26 Nov 2025
- Primary completion26 Dec 2027 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, The Company SOLUTEXGC, S.L
- Responsible party
- Sponsor
- Investigators
- Rosa Maria BRUNO, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038252
- Sponsor's protocol ID
- APHP241105
- Other IDs
- 2025-A00108-41
- Acronym
- SPIN-VA
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared