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The company was acquired by E.I. du Pont de Nemours & Company (DuPont) in 1997. In considering the petition, FDA reviewed data from 27 clinical studies submitted in the petition, as well as comments submitted to the public record and studies identified by FDA. The available research consistently showed that regular soy protein consumption lowered cholesterol to varying degrees.
One of the main studies, conducted over nine weeks at Wake Forest University Baptist Medical Center and reported in the Archives of Internal Medicine in 1999, found that soy protein can reduce plasma concentrations of total and LDL cholesterol but does not adversely affect levels of HDL, or "good" cholesterol, which at high levels has been associated with a reduction in heart disease risk. Another often-quoted study, published in the New England Journal of Medicine in 1995, examined 38 separate studies and concluded that soy protein can prompt "significant reductions" not only in total and LDL cholesterol, but also in triglycerides, another fat linked to health problems when present at elevated levels.
Other studies include that soy may have benefits beyond fostering a healthy heart. At the Third International Symposium on the Role of Soy in Preventing and Treating Chronic Disease, held in late 1999, researchers presented data linking soy consumption to a reduced risk of several illnesses. Disorders as diverse as osteoporosis, prostate cancer, and colon cancer are under investigation.
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