Soy protein products can be good substitutes for animal products because, unlike some other beans, soy offers a "complete" protein profile. Soybeans contain all the amino acids essential to human nutrition, which must be supplied in the diet because they cannot be synthesized by the human body. Soy protein products can replace animal-based foods--which also have complete proteins but tend to contain more fat, especially saturated fat--without requiring major adjustments elsewhere in the diet.
While foreign cultures, especially Asians, have used soy extensively for centuries, mainstream America has been slow to move dietary soy beyond a niche market status. In the United States, soybean is a huge cash crop, but the product is used largely as livestock feed.
With the increased emphasis on healthy diets, that may be changing. Sales of soy products are up and are projected to increase, due in part, say industry officials, to the FDA-approved health claim. (U.S. retail sales of soyfoods were $.852 billion in 1992 and are projected to rise to $3.714 billion in 2002. See attached chart.) "We've seen this before with other claims FDA has approved," says Brian Sansoni, senior manager for public policy at the Grocery Manufacturers of America. "It brings attention to products; there are newspaper and TV stories and information on the Internet."
To qualify for the health claim, foods must contain at least 6.25 grams of soy protein per serving and fit other criteria, such as being low in fat, cholesterol, and sodium. The claim is similar to others the agency has approved in recent years to indicate heart benefits, including claims for the cholesterol-lowering effects of soluble fiber in oat bran and psyllium seeds.
FDA determined that diets with four daily soy servings can reduce levels of low-density lipoproteins (LDLs), the so-called "bad cholesterol" that builds up in blood vessels, by as much as 10 percent. This number is significant because heart experts generally agree that a 1 percent drop in total cholesterol can equal a 2 percent drop in heart disease risk. Heart disease kills more Americans than any other illness. Disorders of the heart and blood vessels, including stroke, cause nearly 1 million deaths yearly.
FDA allowed the health claim for soy protein in response to a petition by Protein Technologies International Inc., a leading soy producer that tracks its origins to soybean studies sponsored by Henry Ford in the early 1930s. 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 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 hint 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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