Derosa Giuseppe, D'Angelo Angela, Romano Davide, Maffioli Pamela
Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, 27100 Pavia, Italy.
Int J Mol Sci. 2017 Feb 7;18(2):343. doi: 10.3390/ijms18020343.
The aim of this study was to evaluate the efficacy and safety of an anti-hypercholesterolemic agent containing , and monacolin K and KA in a sample of Caucasian patients at low cardiovascular risk according to Framingham score. The primary outcome was to evaluate the effects of this nutraceutical combination on lipid profile; the secondary outcome was to evaluate the effect on some inflammatory markers, in particular high sensitivity C-reactive protein and tumor necrosis factor-α interleukin-6. One hundred and forty-three patients were randomized to placebo or Berberol K, once a day, during the dinner, for 3 months, in a randomized, double-blind, placebo-controlled trial. We recorded a significant reduction of fasting plasma glucose with Berberol K compared to placebo (-12.2%, < 0.05). Moreover, we recorded an increase of fasting plasma insulin with Berberol K both compared to baseline and to placebo (+9.9%, < 0.05). Accordingly, the homeostasis model assessment (HOMA) index obtained after treatment with Berberol K was lower than the one in the placebo group (-2.8%, < 0.05). No variations of lipid profile were observed with placebo, while there was a significant decrease of total cholesterol (-20.5%, < 0.05), triglycerides (-17.7%, < 0.05), and low density lipoprotein (LDL) cholestero (-27.8%, < 0.05) with Berberol K, compared to placebo. There was a decrease of high sensitivity C-reactive protein (-30.8%, < 0.05), and interleukin-6 (-25.0%, < 0.05), with Berberol K compared to placebo. In conclusion, combining different hypocholesterolemic nutraceutical agents such as , and monacolin K and KA could be effective and safe to obtain a reduction of lipid profile and an improvement of inflammatory parameters.
本研究的目的是根据弗雷明汉评分，在心血管风险较低的白种人患者样本中，评估一种含有[未提及具体成分]、[未提及具体成分]以及莫纳可林K和KA的抗高胆固醇血症药物的疗效和安全性。主要结局是评估这种营养保健品组合对血脂谱的影响；次要结局是评估对某些炎症标志物的影响，特别是高敏C反应蛋白和肿瘤坏死因子-α、白细胞介素-6。在一项随机、双盲、安慰剂对照试验中，143名患者被随机分为安慰剂组或每天晚餐时服用一次Berberol K组，为期3个月。与安慰剂相比，服用Berberol K后空腹血糖显著降低（-12.2%，P<0.05）。此外，与基线和安慰剂相比，服用Berberol K后空腹血浆胰岛素均有所增加（+9.9%，P<0.05）。因此，服用Berberol K治疗后获得的稳态模型评估（HOMA）指数低于安慰剂组（-2.8%，P<0.05）。安慰剂组未观察到血脂谱变化，而与安慰剂相比，服用Berberol K后总胆固醇显著降低（-20.5%，P<0.05）、甘油三酯降低（-17.7%，P<0.05）、低密度脂蛋白（LDL）胆固醇降低（-27.8%，P<0.05）。与安慰剂相比，服用Berberol K后高敏C反应蛋白降低（-30.8%，P<0.05），白细胞介素-6降低（-25.0%，P<0.05）。总之，联合使用不同的降胆固醇营养保健品，如[未提及具体成分]、[未提及具体成分]以及莫纳可林K和KA，可能有效且安全地降低血脂谱并改善炎症参数。
