||7R03CA072588-02 Interpret this number
||University Of South Florida
||Specific Role of Genistein in Estrogen Metabolism
DESCRIPTION: (Applicant's Description) There is increasing evidence that
phytoestrogens, also referred to as isoflavones, which are derived from soy,
in addition to possessing antiproliferative properties, may alter the plasma
concentration, production, metabolism and excretion of estrogens and their
impact on target tissues. Definitive prospective studies testing the
effects of specific components of isoflavones that alter biomarkers that are
implicated in the initiation and promotion of breast cancer are not
The investigators propose a controlled, randomized clinical trial where 66
pre menopausal, omnivorous, breast cancer free women between ages 25-55 are
randomized to one experimental group supplemented with soy (40 mgs of
genistein/day) or to a control group consuming a placebo, an isocaloric
supplement of casein, for a 12 week period and wish to observe changes in
anthropometric, nutritional and hormonal biomarkers. They hypothesize that
increased intake of genistein will produce an elevation in serum sex-hormone
binding globulin and decrease a free estradiol and estrone. In their pilot
study, they were able to demonstrate the feasibility of their proposal to
maintain a group of women on soy supplementation without altering intake of
other nutrients. In previous studies, they have demonstrated their ability
to monitor changes in anthropometric and sex-hormone variables in similar
populations and in breast cancer patients. If increased intake of soy or
foods rich in phytoestrogens alter the sex hormone milieu, manipulation of
diet, supplemented with foods rich in phytoestrogens such as soy intake by
dietary intervention may reduce breast cancer risk. In addition, based on
the results of this study, prophylactic therapies using dietary supplements
such as genistein, with practically no side effects, may be used to replace
the more controversial therapeutic hormonal supplementation regimens that
are currently used for breast cancer risk reduction. In addition, studies
examining the effect of genistein supplementation, in addition to fat
reduction on both body composition, weight and sex-hormones can be examined
with respect to hormonal cancer risk reduction. Although conducted on a
female population, based on evidence in the current literature, it is
anticipated that this proposed study will generate results which parallel
effects in prostate cancer risk reduction.
The specific role of isoflavones on estrogen metabolism in premenopausal women.
, Cantor A.
, Allen K.
, Riccardi D.
, Cox C.E.
Cancer, 2002-02-15; 94(4), p. 1166-74.