Background – The clinical hypocholesterolemic effect of nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5–10 mg of monacolin K is now well established. For this reason, NCs may be a viable alternative to the statin drugs commonly used to lower cholesterol levels. However, in order to avoid some possible statin-like side effects, most NCs available on the market contain low doses of monacolin K, which could reduce their efficacy. The aim of this study was to investigate the efficacy and safety of a NC containing high doses of monacolin K (10 mg) in improving the lipid profile and glucose metabolism when added to the diet versus the diet alone in a group of hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk. Methods – Thirty subjects with grade-1 essential hypertension (mean age 51.5 ± 7.8 years, 62.9% males) were enrolled in the treatment group (NC group). These subjects followed a programmed diet and took one tablet a day of a NC containing red yeast rice, policosanols, resveratrol and chromium picolinate for 1 month and were compared with an equivalent group of subjects that followed only a diet program. Differences in serum total cholesterol (TC), low-density- and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and blood glucose between groups were compared by analysis of variance. Results – In both groups, a significant reduction of TC, TG and LDLC was observed. In the treatment group from the baseline to the follow-up the reduction of TC (230.93 ± 28.0 vs. 188.63 ± 18.1, p < 0.001) and LDLC (153.10 ± 22.5 vs. 116.54 ± 17.7, p < 0.001) was significantly greater compared to the control group (differences between treatments = 9.19% and 12.29%, respectively); in addition a significant higher reduction in blood glucose (89.1 ± 7.6 vs. 83.7 ± 4.6, p < 0.001) was also observed (differences between treatments = 4.28%). HDLC levels remained unchanged in both groups. Conclusions – In summary, the NC containing high doses of monacolin K appeared to be safe, well tolerated and effective at improving lipid and glucose patterns.

中文翻译：

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短期补充莫纳可林K可改善心血管风险低的高血压和高胆固醇血症受试者的脂质和代谢模式

背景–含有红曲米提取物的营养品化合物（NCs）每天提供2.5-10 mg莫纳可林K的临床降胆固醇作用现已得到证实。因此，NCs可以替代通常用于降低胆固醇水平的他汀类药物。但是，为了避免某些可能的他汀类药物副作用，市场上出售的大多数NC均含有低剂量的莫纳可林K，这可能会降低其功效。这项研究的目的是研究含高剂量莫纳可林K（10 mg）的NC与一组饮食和单独饮食中的饮食相比，改善饮食中的脂质分布和葡萄糖代谢的有效性和安全性。低心血管疾病的高胆固醇血症受试者。方法–治疗组（NC组）招募了30名患有1级原发性高血压的受试者（平均年龄51.5±7.8岁，男性为62.9％）。这些受试者遵循程序饮食，并每天服用一粒含有红曲米，policosanols，白藜芦醇和吡啶甲酸铬的NC，持续1个月，并与仅遵循饮食计划的同等受试者组进行比较。通过方差分析比较两组之间的血清总胆固醇（TC），低密度脂蛋白胆固醇和高密度脂蛋白胆固醇（LDLC和HDLC），甘油三酸酯（TG）和血糖的差异。结果–两组中TC，TG和LDLC均显着降低。在治疗组中，从基线到随访，TC的降低（230.93±28.0 vs.188.63±18.1，p <0.001）和LDLC（153.10±22.5 vs. 116.54±17.7，p <0.001）与对照组相比显着更大（治疗之间的差异分别为9.19％和12.29％）; 此外，还观察到血糖明显降低（89.1±7.6 vs. 83.7±4.6，p <0.001）（治疗之间的差异= 4.28％）。两组的HDLC水平均保持不变。结论–总之，含有高剂量莫纳可林K的NC似乎是安全的，耐受性良好的，并且在改善血脂和血糖水平方面有效。