Oral SPM-enriched marine oil to reduce inflammation-driven vascular ageing in obese people with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.