Minneapolis, MN — Acatris USA Inc., along with Acatris Holding B.V., Giessen, The Netherlands, is pleased to announce that its soy supplement ingredient—SoyLife®—will be the focus of an upcoming women’s health study conducted by researchers at the Baylor College of Medicine, Houston, TX. This $4.5 million study will examine the potential health benefits of soy isoflavone supplementation over a two year period in reducing bone loss in postmenopausal women.
Many women, especially those in various stages of menopause, are interested in nutritional strategies to prevent its onset. Project Director, Dr. William Wong, comments, “According to the most recent report on America's Bone Health by the National Osteoporosis Foundation, approximately 30 million American women aged 50 and older already have osteoporosis or are at risk of developing the disease. The direct medical costs for treating fractures resulting from osteoporosis is estimated to be $17 billion annually. With approximately 76 million baby boomers reaching the age of 50, the number of American women afflicted with osteoporosis and the associated medical costs are going to increase dramatically. Although hormone replacement therapy is effective in preventing osteoporosis, many women are reluctant to start the therapy because of the potential increased cancer risk. Isoflavones, with chemical structures similar to estradiol, are found in abundance in soy protein. In two short-term studies, isoflavones have been shown to reduce bone loss in the lumbar spine of peri- and postmenopausal women. Our project, OPUS (Osteoporosis Prevention Using Soy), is the first large-scale, long-term study to document the safety, efficacy, and optimal dosage of soy isoflavones to prevent osteoporosis in postmenopausal women. If our hypotheses are correct, soy isoflavones will provide a natural alternative to hormone replacement therapy for the prevention of osteoporosis.”
Dr. Wong continued, “The project is designed to document the safety, effectiveness, and optimal dosage of soy isoflavones to prevent osteoporosis in postmenopausal women. The project also has a very strong education and extension component in order to educate the American public about the potential health benefits of soy isoflavones for the prevention of osteoporosis.”
Four hundred women from various multi-ethnic groups will be represented in this two-year, randomized, double-blind, placebo-controlled study. Candidates will be recruited and monitored at four study sites: Baylor College of Medicine, University of Georgia, Iowa State University, and University of California at Davis. One third of the participants will be placed on an 80 mg isoflavone supplement daily, while another third on 120 mg a day, and the last third on placebo. All of the women will be supplemented with 600 mg of calcium and 400 IU of vitamin D each day to ensure an adequate intake of other bone-building nutrients. To monitor safety, mammograms, well-woman examinations, Pap smears, stool guaiac tests, and clinical blood chemistries will be performed. To monitor efficacy, total body and regional bone mineral content and density, as well as biochemical bone markers, will be measured. To determine optimal dosage, changes in bone measurements will be related to blood isoflavone concentrations.
Unlike other research projects, this project has an educational component. Healthcare professionals including medical doctors and registered dietitians, other researchers, extension educators, students (ranging from the high school level to the graduate school level), and consumers will be instructed on the relationship between nutrition and osteoporosis, the health benefits of soy, and how to choose foods consistent with the latest scientific research and dietary recommendations. This will be primarily done by Texas A&M University, which is responsible for conducting conferences, seminars, symposiums and creating education kits and campaigns targeted toward educators, media, consumer groups, and healthcare professionals.
For more information, contact Laurent Leduc, Vice President and General Manager, (USA) at P: 952-920-7700, E: [email protected]; or Marian Verbruggen, PhD, Research & Development Manager, (Europe) at P: 31-183-44-6377, E: [email protected]