KMID : 1161420150180111270
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Journal of Medicinal Food 2015 Volume.18 No. 11 p.1270 ~ p.1273
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Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study
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Cicero Arrigo F. G.
Derosa Giuseppe Pisciotta Livia Barbagallo Carlo
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Abstract
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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¢ç, including 5?mg monacolin K) and 610?mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600?mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; ?42.50?¡¾?18.1?mg/dL), low-density lipoprotein cholesterol (LDL-C; ?37.6?¡¾?13.6?mg/dL), triglycerides (TG; ?19.8?¡¾?25.1?mg/dL), and non-HDL-C (?43.1?¡¾?17.7?mg/dL) (all P?.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (?13.7?¡¾?4.3?mg/dL), LDL-C (?17.6?¡¾?8.5?mg/dL), and non-HDL-C (?14.1?¡¾?5.6?mg/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.
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KEYWORD
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dietary supplements, hypercholesterolemia, monacolins, nutraceuticals, phytosterols, PUFA, red yeast rice
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