Oral SPM-enriched marine oil to reduce inflammation-driven vascular ageing in obese people with high blood pressure
The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients
This trial tests whether taking an oral SPM-enriched marine oil supplement (LIPINOVA) can reduce blood-vessel inflammation and signs of vascular ageing in adults with obesity and controlled hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07038252 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares an oral SPM-enriched marine oil supplement (LIPINOVA) with a matching placebo in adults who are obese and have controlled hypertension. Eligible participants (BMI > 30 kg/m², age 18–85, office BP <140/90 mmHg, stable antihypertensive therapy) receive the active supplement or placebo and are followed for changes related to vascular inflammation and ageing. Outcomes are expected to include inflammatory biomarkers, measures of vascular function or structure, and safety/tolerability, although the registry summary does not list exact endpoints. The study is conducted at Assistance Publique – Hôpitaux de Paris with national and industry collaborators.
Who should consider this trial
Good fit: Adults aged 18–85 with BMI >30 kg/m², hypertension controlled to office BP <140/90 mmHg on stable treatment, able to give informed consent and affiliated with French social security are ideal candidates.
Not a fit: Patients with recent myocardial infarction or stroke (within 6 months), secondary hypertension, severe liver failure, advanced chronic kidney disease (eGFR <30 ml/min/1.73 m²), pregnancy or breastfeeding, or those taking regular NO-donors or phosphodiesterase inhibitors are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the supplement could slow vascular ageing and reduce residual cardiovascular risk in obese patients with hypertension without broadly suppressing immune repair mechanisms.
How similar studies have performed: Anti-inflammatory approaches have reduced cardiovascular events in other trials, but oral SPM supplementation is a relatively novel approach with limited direct clinical trial evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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.
Where this trial is running
Paris
- Service de Pharmacologie - UF Pharmacologie Clinique — Paris, France (Recruiting)
Study contacts
- Principal investigator: Rosa Maria BRUNO — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Tiffany MARTIN
- Email: tiffany.martin@aphp.fr
- Phone: +33144841792
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.