Design and baseline characteristics of a trial on health effects of soy protein with isoflavones in postmenopausal women

Abstract

This study is a double-blind, randomized, placebo-controlled trial to assess the effects of high amounts of phytoestrogens on bone mineral density, cardiovascular diseases, cognitive function, performance in activities of daily life and well being. Participants were healthy postmenopausal women, aged 60-75 years. Between March and September 2000, 202 women were recruited, and, after completion of the baseline measurements, randomized to either soy protein, containing 99 mg naturally occurring isoflavones or placebo (milk protein) daily for 1 year. Analysis of the endpoints will be based on the difference between baseline measurements and measurements at the end of the intervention period with group allocation as independent variable.