{"type":"trials","record":{"id":1249,"source_id":"clinicaltrials-gov","external_id":"NCT07038252","title":"The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients","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.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Assistance Publique - Hôpitaux de Paris","enrollment":60,"countries":["France"],"start_date":"2025-11-26","completion_date":"2027-12-26","last_update_date":"2026-09-14","source_url":"https://clinicaltrials.gov/study/NCT07038252","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T12:17:16.698301+00:00","last_seen_at":"2026-09-25T06:10:49.917+00:00","metadata":{"sex":"ALL","acronym":"SPIN-VA","age_range":"18 Years to 85 Years","comparator":"Control arm :Placebo (olive oil)","organization":"Assistance Publique - Hôpitaux de Paris","interventions":["Oral SPM-enriched marine oil (LIPINOVA)","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Flow-mediated dilation (FMD) — FMD will be measured at Week 0 (baseline), Week 12 (after a first administration period…","Shear rate area under the curve (SR-AUC) — These parameters will be measured at Week 0 (baseline), Week 12 (after a fir…","Difference after 12 -week- intervention with oral SPM supplementation or placebo in arterial stiffness — These paramete…","Change from initiation to the end of the 12 -week- intervention in endothelial injury — These parameters will be measur…","Change from initiation to the end of the 12 -week- intervention immune cell profile — These parameters will be measured…","Insulin sensitivity — These parameters will be measured at Week 0, Week12, Week16, Week28","Change in Body Fat Mass — These parameters will be measured at Week 0, Week12, Week16, Week28","Change in Lipid profile — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Liver function markers — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Renal function markers — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Coagulation markers — These parameters will be measured at Week 0, Week12, Week16, Week28","SPM levels — These parameters will be measured at Week 0, Week12, Week16, Week28","Questionnaires about perceptions and expectations about oral supplements for cardiovascular disease prevention — Week 0…","Health Literacy Questionnaire — Week 28","Questionnaire about vascular ageing awareness — Week 28"],"design_description":"RANDOMIZED · CROSSOVER · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Hypertension","Obesity","Oral SPM-enriched marine oil (LIPINOVA)","Placebo"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: vascular ageing.","quality_checked_at":"2026-09-25T06:10:57.79658+00:00","duplicate_cluster_key":"id:nct07038252","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-11-26 to 2027-12-26","comparator":"Control arm :Placebo (olive oil)","confidence":"structured-source","population":"ALL · 18 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:49.919Z","intervention":["Oral SPM-enriched marine oil (LIPINOVA)","Placebo"],"participants":60,"study_design":"RANDOMIZED · CROSSOVER · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Flow-mediated dilation (FMD) — FMD will be measured at Week 0 (baseline), Week 12 (after a first administration period…","Shear rate area under the curve (SR-AUC) — These parameters will be measured at Week 0 (baseline), Week 12 (after a fir…","Difference after 12 -week- intervention with oral SPM supplementation or placebo in arterial stiffness — These paramete…","Change from initiation to the end of the 12 -week- intervention in endothelial injury — These parameters will be measur…","Change from initiation to the end of the 12 -week- intervention immune cell profile — These parameters will be measured…","Insulin sensitivity — These parameters will be measured at Week 0, Week12, Week16, Week28","Change in Body Fat Mass — These parameters will be measured at Week 0, Week12, Week16, Week28","Change in Lipid profile — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Liver function markers — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Renal function markers — These parameters will be measured at Week 0, Week12, Week16, Week28","Safety assessement by Coagulation markers — These parameters will be measured at Week 0, Week12, Week16, Week28","SPM levels — These parameters will be measured at Week 0, Week12, Week16, Week28","Questionnaires about perceptions and expectations about oral supplements for cardiovascular disease prevention — Week 0…","Health Literacy Questionnaire — Week 28","Questionnaire about vascular ageing awareness — Week 28"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cardiovascular-aging","is_published":true,"match_reasons":["Title contains controlled term: vascular ageing.","Title supplies longevity context: ageing.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Cardiovascular ageing","slug":"cardiovascular-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/1249","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}