SOY INTERVENTION PROGRAM (SIP) STUDY
Wake Forest University, Winston Salem NC
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Abstract
This is a research study of patients with menopausal symptoms, such as hot flashes and night sweats. Currently, physicians prescribe hormones, in the form of pills or patches, to women for the relief of these symptoms unless there are medical reasons not to do so. These reasons include a medical history of blood clots or a strong family history of breast cancer or uterine cancer. While there are benefits of hormones in addition to relief of hot flashes such as protection from osteoporosis (thinning of the bones) and a decrease in heart disease, there are also risks of hormone replacement therapy including the possible increased risk of breast cancer and cancer of the lining of the uterus. Currently, most of these hormones are derived form animal sources. There is research evidence that some plants, including soybeans, contain substances called isoflavones which may prove beneficial in treating women with menopausal symptoms and preserving the benefits of traditional hormone replacement therapy, such as decreasing the risk of heart attack, while avoiding some of the risks of hormone replacement therapy, such as increased risk of breast and uterine cancer. The purpose of this study is to determine if soy protein enriched with isoflavones may be useful in relieving menopausal complaints as well as to determine the effect of soy protein plus isoflavones on blood cholesterol, lab measures of blood clotting and osteoporosis, and hormone levels.
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