The fear and discontent with traditional hormone replacement therapy (HRT) coupled with the interest in natural products has resulted in an increased use of soy protein as a postmenopausal therapeutic alternative by both women and their physicians alike. Evidence from epidemiological and non-human primate studies indicate that isoflavone-rich soy protein has antiatherogenic activity, evidence supported by a large body of data that indicate mechanistic and biologic plausibility. No studies to our knowledge have been published or proposed to determine the long-term effects of soy protein on the progression of atherosclerosis in postmenopausal women. We propose to conduct a 2.5-year, randomized, double-blind, placebo-controlled trial of isoflavone-rich soy protein in 300 healthy postmenopausal women without clinical evidence of cardiovascular disease. We hypothesize that relative to placebo, isoflavone-rich soy protein (supplying genistein, daidzein and glycitein) will reduce the progression of subclinical atherosclerosis in healthy postmenopausal women. The primary end point will be the progression of subclinical atherosclerosis measured as the rate of change in common carotid artery intima-media thickness in computer image processed B-mode ultrasonograms, a well-established noninvasive arterial imaging end point for antiatherosclerosis trials, lsoflavone-rich soy protein may provide a safe and effective alternative approach for extending premenopausal cardioprotection afforded by endogenous estrogen into menopause without the increased risk of thromboembolic events and certain cancers associated with traditional HRT. Since many postmenopausal women are using soy products to maintain their health, it is important to understand whether soy protein has an antiatherogenic effect so that women can make a truly informed decision concerning their expectations of this form of postmenopausal therapy. The question as to whether soy protein is effective in reducing the progression of atherosclerosis in postmenopausal women is not only timely, but also of immense medical and financial importance since atherosclerosis remains the number I killer of postmenopausal women.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AT001653-05
Application #
7284395
Study Section
Special Emphasis Panel (ZRG1-CCVS (01))
Program Officer
Stoney, Catherine
Project Start
2003-09-22
Project End
2009-06-30
Budget Start
2007-07-01
Budget End
2008-06-30
Support Year
5
Fiscal Year
2007
Total Cost
$1,796,742
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