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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Service de Pharmacologie - UF Pharmacologie Clinique
RECRUITING
Paris
Contact Information
Primary
Tiffany MARTIN
tiffany.martin@aphp.fr
+33144841792
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2027-02-26
Participants
Target number of participants: 50
Treatments
Experimental: Experimental arm: active product is Oral SPM-enriched marine oil
Active treatment product is Oral SPM-enriched marine oil (3 gr/day) 3 capsules after breakfast and 3 capsules after dinner, provided by Solutex.
Placebo_comparator: Control arm :Placebo (olive oil)
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
Sponsors
Collaborators: National Research Agency, France, The Company SOLUTEXGC, S.L
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

Similar Clinical Trials