OMECARDIO trial: a randomized, double-blind, placebo-controlled study on the impact of omega-3 on inflammageing biomarkers and vascular stiffness in hypertensive and dyslipidemic patients

Abstract Objective This study aimed to evaluate the effects on inflammatory biomarkers and vascular stiffness of a 12-week daily supplementation with 2 grams of omega-3 in individuals with hypertension and dyslipidaemia. Secondary objectives included evaluating the safety and tolerability of moderate dose of a omega-3 in this population. Design and Method: This was a randomized, double-blind, placebo-controlled clinical trial including 100 adults with hypertension and dyslipidemia. Participants were randomly assigned (1:1) to receive either 2 grams of omega-3 ethyl esters (46% EPA, 38% DHA, and 4 mg of soy alpha-tocopherol) 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 enrolment. Outcomes included a composite endpoint, defined as a ≥10% reduction in at least two of the three inflammatory markers: ferritin, high-sensitivity C-reactive protein, and neutrophil-to-lymphocyte ratio. We also evaluate O3 effects on vascular distensibility (PWV, m/sec); central-aortic systolic blood pressure and office blood pressure /24-hour ambulatory blood pressure. 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). The inflammatory composite outcome was achieved in 72.73% of O3- treated participants versus 30.95% in the placebo group (p0.001). The omega-3 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 (p0.001), and reductions were observed in 24-hour ambulatory systolic blood pressure (p=0.002) and central blood pressure (p=0.022). Conclusions The reduction in levels of inflammatory biomarkers and vascular stiffness associated with the intake of 2 grams of omega-3 daily in patients with higher cardiovascular risk due to hypertension and dyslipidemia suggests that this could be a highly accessible and scalable strategy to address the challenge of inflammaging in this population. While this is a surrogate outcome, it is linked to an increased risk of accelerated aging and events, particularly in an era of rising longevity and the need to reduce exposure to chronic systemic inflammation.