Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study

Abstract

The main guidelines for cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both red yeast rice and polyunsaturated fatty acids (PUFAs) and a phytosterol-based approach in a setting of clinical practice. This was a multicenter open study with parallel control. We consecutively enrolled 107 pharmacologically untreated subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome, assigned to 8-week treatment with a combined treatment with red yeast rice (Dif1Stat®, including 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6±13.6mg/dL), triglycerides (TG; -19.8±25.1mg/dL), and non-HDL-C (-43.1±17.7mg/dL) (all P<.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7±4.3mg/dL), LDL-C (-17.6±8.5mg/dL), and non-HDL-C (-14.1±5.6mg/dL) (all P<.001). When comparing the combined nutraceutical effect with that of phytosterols, we observed that the combined nutraceutical intake was associated with a significantly higher decrease in TC, LDL-C, TG, and non-HDL-C (all P<.001). In the short term, a combined nutraceutical containing red yeast rice and PUFAs is well tolerated and efficacious in reducing plasma lipid levels in subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome.