The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients

NCT07038252 | Recruiting

• 2 other identifiers: APHP2411052025-A00108-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension; Obesity

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation (FMD)

  Conduit-artery endothelial function measured by flow-mediated dilation (FMD) after 12 week-intervention with oral SPM supplementation or placebo.

  FMD will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 14 (after a wash-out period of 2 weeks ± 2 days), Week 26 (after a second administration period of 12 weeks ± 2 days)

Secondary Outcomes (14)

• Shear rate area under the curve (SR-AUC)

  These parameters will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 14 (after a wash-out period of 2 weeks ± 2 days), Week 26 (after a second administration period of 12 weeks ± 2 days)

• Difference after 12 -week- intervention with oral SPM supplementation or placebo in arterial stiffness

  These parameters will be measured at Week 0 (baseline), Week 12 (after a first administration period of 12 weeks ± 2 days) , Week 14 (after a wash-out period of 2 weeks ± 2 days), Week 26 (after a second administration period of 12 weeks ± 2 days)

• Change from initiation to the end of the 12 -week- intervention in endothelial injury

  These parameters will be measured at Week 0 (baseline), Week 12, Week 14, Week 26.

• Change from initiation to the end of the 12 -week- intervention immune cell profile

  These parameters will be measured at Week 0, Week12, Week14, Week26

• Insulin sensitivity

  These parameters will be measured at Week 0, Week12, Week14, Week26

Study Arms (2)

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.

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

Dietary Supplement: Placebo

Interventions

Oral SPM-enriched marine oil (LIPINOVA) DIETARY_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.

Also known as: SPM-enriched marine oil, Omega-3 free fatty acids with SPM precursors, Specialized pro-resolving mediator supplement

Experimental arm: active product is Oral SPM-enriched marine oil

Placebo DIETARY_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

Control arm :Placebo (olive oil)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years,.
• BMI \> 30 kg/m²,
• Signed informed consent,
• Social security affiliation.

You may not qualify if:

• 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,
• Any supplementation with omega-3 or omega-6 polyunsaturated fatty acids within the past month,

Sponsors & Collaborators

• National Research Agency, France: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• The Company SOLUTEXGC, S.L: collaborator

Study Sites (1)

Service de Pharmacologie - UF Pharmacologie Clinique

Paris, France

RECRUITING

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rosa Maria BRUNO

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany MARTIN

CONTACT

+33144841792; tiffany.martin@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 26, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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).

Locations

FR (1)