Yang Nae-Cherng, Chou Chien-Wen, Chen Chung-Yin, Hwang Kai-Lin, Yang Yi-Chueh
Department of Nutrition and Health Science, Chungchou Institute of Technology, Changhua 510, Taiwan.
Asia Pac J Clin Nutr. 2009;18(3):310-7.
The purpose of this randomized, double-blind, placebo-controlled, parallel comparison study was to evaluate the lipid-lowering effect of orally administrated nattokinase and nattokinase combined with red yeast rice (RYR) extract on blood lipids in patients with hyperlipidemia. A total of 47 patients with hyperlipidemia were assigned to one of three groups: 1. nattokinase-mono formula (50 mg/capsule), 2. combined formula of nattokinase with RYR (300 mg of extract/capsule) and 3. placebo. Subjects received a twice daily dose of two capsules for six months. The mono formula showed no effects on blood lipids until month six, while the combined formula ameliorated all of measured lipids starting from month one. In the combined group significant decreases were found with regard to: triglycerides (TG) by 15%, total cholesterol (TC) by 25%, low-density lipoprotein cholesterol (LDL-C) by 41%, TC/high-density lipoprotein cholesterol (HDL-C) ratio by 29.5%, and increases in HDL-C by 7.5%. These changes were sustained until the end of study. After controlling for baseline levels, only the combined group, but not mono group, showed a significant difference (p<0.0001) in TC, LDL-C and TC/HDL-C ratio when compared with the placebo group. In summary, this study provides long-term efficacy of nattokinase supplementation and shows that the combined formula has relatively more potent effects than the mono formula on lowering of blood lipids, suggesting that combined nattokinase with RYR will be a better neutraceutical for patients with hyperlipidemia than nattokinase alone.
这项随机、双盲、安慰剂对照、平行比较研究的目的是评估口服纳豆激酶以及纳豆激酶与红曲米（RYR）提取物联合使用对高脂血症患者血脂的降脂效果。总共47名高脂血症患者被分配到三组中的一组：1. 纳豆激酶单一配方（50毫克/胶囊），2. 纳豆激酶与RYR的联合配方（300毫克提取物/胶囊），3. 安慰剂。受试者每天服用两次，每次两粒胶囊，持续六个月。单一配方直到第六个月对血脂都没有影响，而联合配方从第一个月开始就改善了所有测量的血脂指标。在联合组中，发现甘油三酯（TG）显著降低15%，总胆固醇（TC）降低25%，低密度脂蛋白胆固醇（LDL-C）降低41%，TC/高密度脂蛋白胆固醇（HDL-C）比值降低29.5%，HDL-C升高7.5%。这些变化一直持续到研究结束。在控制基线水平后，与安慰剂组相比，只有联合组，而不是单一配方组，在TC、LDL-C和TC/HDL-C比值方面显示出显著差异（p<0.0001）。总之，本研究提供了补充纳豆激酶的长期疗效，并表明联合配方在降低血脂方面比单一配方具有相对更强的效果，这表明纳豆激酶与RYR联合使用对高脂血症患者来说将是一种比单独使用纳豆激酶更好的营养保健品。
