Charles E. Schmidt College of Medicine, Florida Atlantic University, 880 NW 13th street, Suite 1B, Boca Raton, FL 33486, USA.
J Clin Lipidol. 2012 Mar-Apr;6(2):150-8. doi: 10.1016/j.jacl.2011.09.004. Epub 2011 Sep 21.
We hypothesized that a nutraceutical formulation containing small amounts of bioactive constituents that exert cholesterol-lowering effects by different mechanisms may exhibit synergistic efficacy with a clean tolerability profile. The purpose of this study was to evaluate nutraceutical fruit-flavored drinks with and without red yeast rice (RYR) for effects on low-density lipoprotein (LDL) and total cholesterol.
In double-blinded fashion, 79 subjects were randomized to one of three fruit-flavored drinks, ie, a placebo, and two active drinks containing niacin, phytosterol esters, L-carnitine, vitamin C, and Co-Q-10, one with and without RYR, twice daily. Primary end points were LDL and total cholesterol percent reductions from baseline. Secondary end points were high-density lipoprotein and C-reactive protein percent change from baseline. Physician contact and laboratory work were obtained at baseline, 4 weeks, and 8 weeks of subject participation.
A total of 59 subjects completed the study. The placebo group and the group receiving the nutraceuticals without RYR showed no change in primary or secondary end points. The nutraceutical drink with RYR reduced total cholesterol at week 4 by 13% (-35 mg/dL) and week 8 by 14% (-46 mg/dL). LDL cholesterol decreased 17.1% at 4 weeks (-28 mg/dL) and 17.8% at week 8 (-30 mg/dL). In the effective drink arm containing nutraceuticals and RYR there were no biochemical or subjective intolerance, with the exception of one subject who experienced headache.
A nutraceutical drink with RYR can be a safe and effective natural alternative to pharmacologic therapies for people intolerant to or refusing statins but still in need of achieving and maintaining a healthy and low cholesterol level.
我们假设一种含有少量生物活性成分的营养配方，这些成分通过不同的机制发挥降低胆固醇的作用，可能与清洁耐受性有关。本研究的目的是评估含有或不含有红曲米（RYR）的营养水果饮料对低密度脂蛋白（LDL）和总胆固醇的影响。
在双盲的情况下，79 名受试者被随机分为三组水果味饮料，即安慰剂组和两种含有烟酸、植物甾醇酯、左旋肉碱、维生素 C 和 Co-Q-10 的活性饮料，一种含有 RYR，另一种不含有 RYR，每天两次。主要终点是 LDL 和总胆固醇从基线的百分比降低。次要终点是高密度脂蛋白和 C 反应蛋白从基线的百分比变化。在受试者参与的基线、4 周和 8 周时，进行了医生接触和实验室工作。
共有 59 名受试者完成了研究。安慰剂组和不含有 RYR 的营养组在主要和次要终点均无变化。含有 RYR 的营养饮料在第 4 周总胆固醇降低 13%（-35mg/dL），第 8 周降低 14%（-46mg/dL）。LDL 胆固醇在第 4 周降低 17.1%（-28mg/dL），第 8 周降低 17.8%（-30mg/dL）。在含有营养成分和 RYR 的有效饮料组中，除了一名出现头痛的受试者外，没有生化或主观不耐受。
对于不能耐受或拒绝他汀类药物但仍需要达到和维持健康低胆固醇水平的人来说，含有 RYR 的营养饮料可以作为一种安全有效的天然替代药物疗法。
