Α Randomized, Placebo-Controlled Trial to assess the Efficacy and Safety of a Novel Nutraceutical Combination of Monacolin K and Bergamot extract in subjects with Mild to Moderate Hypercholesterolemia

Background: Lipid-lowering therapy is the primary treatment for hypercholesterolemia, with statins as the first-line therapy. Nutraceuticals like bergamot, RYR, and berberine have been shown to be effective in reducing Low-density Lipoprotein (LDL-C) and total cholesterol (TC) levels. This study assessed the safety and efficacy of a novel nutraceutical supplement for mild to moderate hypercholesterolemia and low cardiovascular risk. Materials and methods: A prospective, multicentric, open-label, randomized controlled trial was conducted at four outpatient endocrine clinical centers in Greece. Patients were over 40 years old, had mild hypercholesterolemia, and did not require statin treatment according to guidelines. 66 subjects with mild hypercholesterolemia and a 10-year atherosclerotic cardiovascular disease risk (ASCVD Risk) <7.5% were included in the study. Mediterranean diet and the nutraceutical compound were prescribed to 34 patients at random for eight weeks, while 30 patients comprised the diet-only control group. Results: No significant changes were observed in Body mass index, TC, and High-density Lipoprotein concentrations between the two groups. A significant median reduction of 13.25% in LDL-C levels was achieved in the treated group and no adverse effects were reported. Conclusion: These results suggest that the investigated nutraceutical compound could serve as a potential alternative treatment, particularly for certain patient populations, such as those who are intolerant to statins or who refuse lipid-lowering drug therapy.