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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Hypertension; Obesity

Treatments: Dietary Supplement: Oral SPM-enriched marine oil (LIPINOVA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07038252

APHP241105

2025-A00108-41 (Other Identifier)

Details and patient eligibility

About

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 50 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 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 on the basis of medical history,
• Myocardial infarction 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

Active treatment product is Oral SPM-enriched marine oil (3 gr/day) 3 capsules after breakfast and 3 capsules after dinner, provided by Solutex.

Treatment:

Dietary Supplement: Oral SPM-enriched marine oil (LIPINOVA)

Control arm :Placebo (olive oil)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo