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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether taking a special dietary supplement called SPM (specialized pro-resolving mediators), which comes from natural fats found in foods like fish, can help reduce inflammation and improve blood vessel health in people who are both obese and have high blood pressure. Inflammation can cause damage inside blood vessels, increasing the risk of heart problems, even when other treatments are working well. Researchers want to see if this supplement can help the body better heal and protect blood vessels, potentially lowering the chance of heart disease.

The study plans to include about 50 adults aged 18 to 75 who have obesity (a body mass index over 30) and controlled high blood pressure. Participants should be on stable treatment for blood pressure and not have other serious health issues like recent heart attacks, strokes, or kidney failure. If you join, you will take the supplement by mouth, and the researchers will carefully monitor how your blood vessels, inflammation, and overall health respond. This trial is not yet recruiting but aims to offer new ways to reduce heart risks safely by supporting the body’s natural healing processes.

Gender

ALL

Eligibility criteria

• 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.