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Context: The purpose of this review was to critically evaluate current research on the effect of soy protein and isoflavone supplements on plasma lipoproteins and place the potential role of soy in the prevention of coronary artery disease (CAD) into a clinical perspective. Evidence Acquisition: An extensive literature search was performed using a variety of medical and scientific databases including Medline, PubMed, Science Direct, Ovid, NIST, and Infotrac to identify relevant articles. Journal articles were cross-referenced for additional sources of information. Articles were evaluated based on level of experimental control as well as statistical, quantitative, and clinical analysis. Evidence Synthesis: Soy and soy isoflavones have been the object of extensive research investigating their potential hypocholesterolemic effects and possible role in the prevention of CAD. It has been suggested that soy, especially the isoflavones contained in soy, improves lipoprotein levels, thus reducing the risk for CAD. This belief, however, is not uniformly accepted. Moreover, the experimental evidence in support of this notion is not as overwhelming as generally perceived, and the current available data reveal that the discrepancies observed are primarily statistical in nature rather than reflecting actual quantitative differences in the hypocholesterolemic effects detected. Conclusions: A critical analysis of the investigations to date indicates the data are not quantitatively impressive and raises substantial questions about the clinical importance of the hypocholesterolemic effects observed.

A Critical Evaluation of the Role of Soy Protein and Isoflavone Supplementation in the Control of Plasma Cholesterol Concentrations