A study of women's bone health to be carried out by the Baylor College of Medicine in Houston, Texas, is to investigate the potential benefits of soy isoflavone supplementation, in particular those found in SoyLife, the soy supplement ingredient produced by Acatris, the newly-formed division of the Royal Schouten group.
The $4.5 million (€4.8m) study will examine the potential health benefits of soy isoflavone supplementation over a two year period in reducing bone loss in postmenopausal women.
Dr William Wong, the leader of the research project, said: "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."
He added that although hormone replacement therapy was effective in preventing osteoporosis, many women were reluctant to start the therapy because of the potential increased cancer risk. "Isoflavones, with chemical structures similar to estradiol (an oestogenic hormone), 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."
He said that the project was designed to document the safety, effectiveness, and optimal dosage of soy isoflavones to prevent osteoporosis in postmenopausal women. It also had a very strong education and extension component, he added, which was designed 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 the two-year, randomised, double-blind, placebo-controlled study. Candidates will be recruited and monitored at four study sites across the US.
One third of the study participants will be given 80mg of isoflavone supplements per day, with another third on 120mg a day and the remaining third being given a placebo. All of the women will be supplemented with 600mg 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.
The educational component of the research will involve instructing doctors, dietitians, teachers, students and consumers about 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 educational programme will be carried out primarily 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.