1 Department of Nutritional Sciences Faculty of Medicine University of Toronto Ontario Canada.
2 Department of Medicine Faculty of Medicine University of Toronto Ontario Canada.
J Am Heart Assoc. 2019 Jul 2;8(13):e012458. doi: 10.1161/JAHA.119.012458. Epub 2019 Jun 27.
Background Soy protein foods have attracted attention as useful plant protein foods with mild cholesterol-lowering effects that are suitable for inclusion in therapeutic diets. But on the basis of the lack of consistency in significant cholesterol reduction by soy in 46 randomized controlled trials, the US Food and Drug Administration (FDA) is reassessing whether the 1999 heart health claim for soy protein should be revoked. Methods and Results We have, therefore, performed a cumulative meta-analysis on the 46 soy trials identified by the FDA to determine if at any time, since the 1999 FDA final rule that established the soy heart health claim, the soy effect on serum cholesterol lost significance. The cumulative meta-analysis for both total cholesterol and low-density lipoprotein cholesterol demonstrated preservation of the small, but significant, reductions seen both before and during the subsequent 14 years since the health claim was originally approved. For low-density lipoprotein cholesterol, the mean reduction in 1999 was -6.3 mg/dL (95% CI, -8.7 to -3.9 mg/dL; P=0.00001) and remained in the range of -4.2 to -6.7 mg/dL ( P=0.0006 to P=0.0002, respectively) in the years after 1999. At no time point did the total cholesterol or low-density lipoprotein cholesterol reductions lose significance or were the differences at individual time points in the cumulative meta-analysis significantly different from those seen in 1999 when the health claim was approved. Conclusions A cumulative meta-analysis of the data selected by the FDA indicates continued significance of total cholesterol and low-density lipoprotein cholesterol reduction after soy consumption and supports the rationale behind the original soy FDA heart health claim.
背景 大豆蛋白食品因其具有温和的降胆固醇作用，适合纳入治疗性饮食，因此作为有用的植物蛋白食品引起了关注。但是，由于 46 项随机对照试验中大豆在显著降低胆固醇方面缺乏一致性，美国食品和药物管理局（FDA）正在重新评估是否应该撤销 1999 年针对大豆蛋白的心脏健康声明。
方法和结果 因此，我们对 FDA 确定的 46 项大豆试验进行了累积荟萃分析，以确定自 1999 年 FDA 最终确定大豆心脏健康声明以来，大豆对血清胆固醇的影响是否在任何时候失去意义。对总胆固醇和低密度脂蛋白胆固醇的累积荟萃分析表明，在最初批准健康声明后的 14 年中，都保留了之前和之后看到的小但显著的降低。对于低密度脂蛋白胆固醇，1999 年的平均降低幅度为-6.3mg/dL（95%CI，-8.7 至-3.9mg/dL；P=0.00001），并且在 1999 年之后的几年中仍处于-4.2 至-6.7mg/dL 的范围内（P=0.0006 至 P=0.0002，分别）。在任何时间点，总胆固醇或低密度脂蛋白胆固醇的降低都没有失去意义，或者累积荟萃分析中各个时间点的差异与批准健康声明时的 1999 年没有显著不同。
结论 FDA 选择的数据的累积荟萃分析表明，大豆消费后总胆固醇和低密度脂蛋白胆固醇的降低仍然具有重要意义，并且支持了原始 FDA 大豆心脏健康声明背后的基本原理。
