Effects of a Multi-Component Nutraceutical (NUT2) on the Lipid Profile in Adults with Low-to-Moderate Cardiovascular Risk: A Randomized Placebo-Controlled Trial

Background: Lifestyle intervention is recommended as first-line management for individuals with low-to-moderate cardiovascular (CV) risk and elevated low-density lipoprotein cholesterol (LDL-C), although dietary intervention alone often produces only modest lipid reductions. NUT2 is a proprietary multi-component nutraceutical formulated to target complementary pathways involved in lipid metabolism, oxidative stress and cardiometabolic risk. This study evaluated its efficacy and safety as an adjunct to dietary intervention. Methods: In this randomized, double-blind, placebo-controlled, parallel-group study, 90 adults with low-to-moderate CV risk and elevated LDL-C were randomized to receive NUT2 (n = 45) or placebo (n = 45) for 12 weeks, together with standardized dietary advice. The primary endpoint was a change in LDL-C at Week 12. Secondary outcomes included changes in total cholesterol, triglycerides, fasting glucose, fasting insulin, high-sensitivity C-reactive protein (hsCRP), homocysteine, anthropometric parameters, blood pressure and metabolic syndrome prevalence. Results: Baseline characteristics were generally comparable, although baseline lipid values differed between groups and were accounted for using baseline-corrected change scores. At Week 12, LDL-C decreased by 13.2% with NUT2 and increased by 1.6% with placebo; the baseline-corrected between-group difference was −23 mg/dL (95% CI −29 to −16; p < 0.001). Total cholesterol was also significantly reduced (corrected difference −26 mg/dL, 95% CI −36 to −17; p < 0.001). Significant reductions in homocysteine and lower fasting insulin concentrations were observed with NUT2. Metabolic syndrome prevalence was 13.3% with NUT2 versus 37.8% with placebo at Week 12 (p = 0.008), although this exploratory finding was based on small participant numbers. No significant between-group difference was observed for hsCRP. NUT2 was well tolerated, with no serious treatment-related adverse events. Conclusions: In adults with low-to-moderate cardiovascular risk whose LDL-C remained suboptimal despite dietary intervention, NUT2 produced significant and clinically relevant improvements in LDL-C and total cholesterol over 12 weeks. The significant reduction in homocysteine further supports the broader biological activity of the multi-component formulation. Favourable changes in insulin and metabolic syndrome status suggest potential additional metabolic effects, although these findings warrant further investigation in larger studies specifically designed for populations with metabolic dysfunction. NUT2 was safe and well tolerated. (Clinical trial registry: NCT07492264; trial registration number: NCT07492264, registration date: 23 March 2026.)