An interventional study of Oral SPM-enriched marine oil (LIPINOVA) and Placebo in Hypertension and Obesity, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Among 17 studies in Hypertension by Assistance Publique - Hôpitaux de Paris — 5 open to participants now, 5 under way, none of them phase 3. Hypertension · Assistance Publique - Hôpitaux de Paris.
Among the 17 studies in Hypertension by Assistance Publique - Hôpitaux de Paris, this one is the 9th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2025, is one of 9 with no phase, and was the 14th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →5 of the 17 studies in Hypertension by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
By country, each count listing its studies:
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 60 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Median enrollment 219 across the 11 interventional studies, 160 across the 6 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
2 of the studies in Hypertension by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07675434Assistance Publique - Hôpitaux de ParisProspective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting | 2027-02-01 |
| NCT05917600Assistance Publique - Hôpitaux de ParisImpact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control | 2027-06 |
Among the 17 studies in Hypertension by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active treatment product is Oral SPM-enriched marine oil (3 gr/day) 3 capsules after breakfast and 3 capsules after dinner, provided by Solutex.
Dietary Supplement: Oral SPM-enriched marine oil (LIPINOVA)
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
Dietary Supplement: Placebo
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.
Also known as: SPM-enriched marine oil, Omega-3 free fatty acids with SPM precursors, Specialized pro-resolving mediator 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.
Also known as: Olive oil capsules, Placebo SPM supplement
Flow-mediated dilation (FMD)
Conduit-artery endothelial function measured by flow-mediated dilation (FMD) after 12 week-intervention with oral SPM supplementation or placebo.
Time frame: 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)
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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: These parameters will be measured at Week 0, Week12, Week16, Week28
SPM levels
SPM levels
Time frame: 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.
Time frame: 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.
Time frame: Week 28
Questionnaire about vascular ageing awareness
Questionnaire about vascular ageing awareness
Time frame: Week 28
Plan to share: 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
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
Access criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 25 months is close to that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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