OMECARDIO: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE IMPACT OF OMEGA-3 ON BLOOD PRESSURE, VASCULAR FUNCTION, AND INFLAMMATION

Objective: This study aimed to evaluate the effects of 12 weeks of daily supplementation with 2 grams of omega-3(O3) in individuals with hypertension and dyslipidemia, in addition to their stable specific treatment. We assessed O3 impact on blood pressure, vascular distensibility, and biomarkers of chronic systemic inflammation. Secondary objectives included evaluating the safety and tolerability of omega-3 supplementation in this population. Design and method: This was a randomized, double-blind, placebo-controlled clinical trial including 100 adults with hypertension and dyslipidemia (ClinicalTrials.gov identifier: NCT06840964). Participants were randomly assigned 1:1 to receive either 2 grams of omega-3 ethyl esters or a matching placebo daily for 12 weeks. Eligible participants were aged 21–85 years and had been on stable antihypertensive and lipid-lowering therapy for at least three months before enrollment. Outcomes included office blood pressure (peripheral and central), 24-hour ambulatory blood pressure, pulse wave velocity, three plasma biomarkers of inflammation (ferritin, high-sensitivity C-reactive protein, and neutrophil-to-lymphocyte ratio), and overall cardiometabolic profile. Results: Out of the 150 hypertensive dyslipidemic patients evaluated, a final population of 100 was included, with 95 completing the intervention study (57,3 ±10,8 y; 54% female), a composite endpoint, defined as an equal or higher than 10% reduction in at least two of the three inflammatory markers, was achieved in 72.73% of O3-treated participants versus 30.95% in the placebo group (p<0.001). The O3 group showed a greater reduction in ferritin levels (40.43% vs. 18.18%, p=0.024), neutrophil-to-lymphocyte ratio (84.09% vs. 47.62%, p=0.001), and hs-CRP (68.89% vs. 36.36%, p=0.005). Additionally, pulse wave velocity significantly improved (p<0.001), and reductions were observed in 24-hour ambulatory systolic blood pressure (p=0.002) and central blood pressure (p=0.022).Conclusions: Twelve-week supplementation with 2 grams of omega-3 reduced blood pressure, improved vascular distensibility and systemic inflammation in adults with hypertension and dyslipidaemia. The OMECARDIO trial supports the hypothesis to be explored in larger populations of patients with arterial hypertension, focusing on the potential antihypertensive effect mediated by the favorable impact on distensibility and inflammation. Note: Acknowledgment to Dr. Eduardo Adaniya and to Laboratorio Gador to their support in the development of this trial.