This application is a supplement to a recently funded randomized controlled trial, Phytoestrogens in Progression of Atherosclerosis (U01-AT001653). This supplement is focused on isoflavone (iso)-rich soy protein supplementation and breast cancer risk in postmenopausal women. Evidence from observational studies indicates that soy intake may reduce breast cancer risk. If beneficial effects of soy can be demonstrated in a randomized controlled trial using mammographic percent density (MPD), an established marker of breast cancer risk, this will considerably strengthen the results obtained from observational studies. Design, duration and size of the parent trial make it an ideal platform upon which to adequately assess the effects of iso-rich soy protein supplementation on breast cancer risk. Since the central portion of the trial has been funded, a very robust database will be obtained at considerable savings. The objective of this supplement is to investigate the effect of iso-rich soy protein supplementation on breast cancer risk in 300 healthy postmenopausal women in a randomized, double-blind, placebo-controlled, 2.5 year trial. The primary Specific Aims are to study the effects of iso-rich soy protein supplementation on MPD and circulating female sex hormone levels (estrogen, progesterone, prolactin, sex hormone binding globulin [SHBG]). Specifically, changes in MPD and circulating hormone levels will be compared between treatment groups (Specific Aims 1 and 2). There are several inter-related secondary objectives designed to investigate potential individual differences in response to supplementation. Among women randomized to the soy arm (n=150), we will determine whether blood isoflavone levels predict changes in MPD (Specific Aim 3) and circulating hormone levels (Specific Aim 4). We will determine whether changes in MPD (Specific Aim 6) and circulating hormone levels (Specific Aim 7) are influenced by polymorphisms in selected genes involved with estrogen and progesterone synthesis and metabolism that are thought to be affected by soy isoflavones. We will determine whether changes in blood hormone levels predict changes in MPD among women randomized to the soy arm (Specific Aim 5). Finally, using baseline measurements of all subjects (n=300), we will determine the relationship between MPD and circulating sex hormone levels (Specific Aim 8). ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AT001653-02S2
Application #
6830059
Study Section
Clinical Oncology Study Section (CONC)
Program Officer
Wong, Shan S
Project Start
2003-09-22
Project End
2009-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
2
Fiscal Year
2004
Total Cost
$347,978
Indirect Cost
Name
University of Southern California
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Kurita, Keiko; Henderson, Victor W; Gatz, Margaret et al. (2016) Association of bilateral oophorectomy with cognitive function in healthy, postmenopausal women. Fertil Steril 106:749-756.e2
Karim, Roksana; Dang, Ha; Henderson, Victor W et al. (2016) Effect of Reproductive History and Exogenous Hormone Use on Cognitive Function in Mid- and Late Life. J Am Geriatr Soc 64:2448-2456
Alexy, Tamas; Pais, Eszter; Wenby, Rosalinda B et al. (2015) Abnormal blood rheology and chronic low grade inflammation: possible risk factors for accelerated atherosclerosis and coronary artery disease in Lewis negative subjects. Atherosclerosis 239:248-51
St John, Jan A; Henderson, Victor W; Hodis, Howard N et al. (2014) Associations between urine excretion of isoflavonoids and cognition in postmenopausal women in the Women's Isoflavone Soy Health clinical trial. J Am Geriatr Soc 62:629-35
Mucowski, Sara J; Mack, Wendy J; Shoupe, Donna et al. (2014) Effect of prior oophorectomy on changes in bone mineral density and carotid artery intima-media thickness in postmenopausal women. Fertil Steril 101:1117-22
Gatto, Nicole M; Henderson, Victor W; Hodis, Howard N et al. (2014) Components of air pollution and cognitive function in middle-aged and older adults in Los Angeles. Neurotoxicology 40:1-7
Quaas, Alexander M; Kono, Naoko; Mack, Wendy J et al. (2013) Effect of isoflavone soy protein supplementation on endometrial thickness, hyperplasia, and endometrial cancer risk in postmenopausal women: a randomized controlled trial. Menopause 20:840-4
Henderson, V W; St John, J A; Hodis, H N et al. (2012) Long-term soy isoflavone supplementation and cognition in women: a randomized, controlled trial. Neurology 78:1841-8
Franke, Adrian A; Lai, Jennifer F; Halm, Brunhild M et al. (2012) Equol production changes over time in postmenopausal women. J Nutr Biochem 23:573-9
Hodis, Howard N; Mack, Wendy J; Kono, Naoko et al. (2011) Isoflavone soy protein supplementation and atherosclerosis progression in healthy postmenopausal women: a randomized controlled trial. Stroke 42:3168-75

Showing the most recent 10 out of 13 publications