Trial Information

Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones

OBJECTIVES: I. Determine the effect of varying the dietary intake of soy nuts on plasma
levels and urinary excretion of isoflavones. II. Determine the effects of different food
composition, along with age and gender of subjects, on plasma levels and urinary excretion
of isoflavones.

OUTLINE: This is a two part study. In part I; participants are stratified according to
menopausal status. In part II; participants are stratified according to gender and age
(under 50 vs. over 50). Part I - Study participants are given 3 different amounts of toasted
soy nuts separated by one month intervals. The sequence in which each amount is given is
randomized. Blood and urine samples are taken to measure isoflavone levels. Part II - Study
participants are given toasted soy nuts, soy milk, and tempeh on separate occasions
separated by one month intervals. The sequence of each food is randomized. Blood and urine
samples are taken to measure isoflavone levels.

PROJECTED ACCRUAL: 10 women, 5 premenopausal and 5 postmenopausal, will be accrued for part
I of the study. 80 subjects, 40 women and 40 men, will be accrued for part II.