Women will live a third of their lives in menopause. The complications of prolonged estrogen deficiency during the menopausal years are well established. Although hormone replacement therapy (HRT) can spare women some of these complications, the Women's Health Initiative findings indicate significant potential health risks, risks that prompt more and more women to turn from prescribed HRT to over-the-counter products in the hope that soy phytoestrogens and other 'estrogens' from natural sources can replace prescription estrogens in terms of benefits while sparing critical side effects. In spite of the fairly widespread and now rapidly growing use o f phyto estrogens, maj or gap s remain in our knowledge o f their long-term efficacy and safety. We propose to conduct a 'Soy Phytoestrogens As Replacement Estrogen (SPARE)' study in young menopausal women to evaluate the effectiveness of a 2-year treatment with purified soy isoflavones in preventing bone loss. Our study will also explore the effectiveness of oral isoflavones in preventing menopausal symptoms and other changes associated with estrogen deficiency. The study will characterize the actions of a defined preparation of soy isoflavones in humans and will correlate these actions with the circulating serum levels of the principal isoflavone metabolites, providing new insights on their long term biological actions. This 5-year study will provide a foundation of knowledge from which menopausal women can begin to make more informed decisions regarding HRT and menopausal signs and symptoms.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR048932-05
Application #
7408656
Study Section
Special Emphasis Panel (ZRG1-EDC-3 (01))
Program Officer
Mcgowan, Joan A
Project Start
2003-09-01
Project End
2010-03-31
Budget Start
2008-04-01
Budget End
2010-03-31
Support Year
5
Fiscal Year
2008
Total Cost
$486,167
Indirect Cost
Name
University of Miami School of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
052780918
City
Coral Gables
State
FL
Country
United States
Zip Code
33146
Lagari, Violet S; Levis, Silvina (2013) Phytoestrogens in the prevention of postmenopausal bone loss. J Clin Densitom 16:445-9
Levis, Silvina; Strickman-Stein, Nancy; Ganjei-Azar, Parvin et al. (2011) Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med 171:1363-9
Griebeler, Marcio L; Levis, Silvina; Beringer, Laura Muñoz et al. (2011) Self-reported versus measured height and weight in Hispanic and non-Hispanic menopausal women. J Womens Health (Larchmt) 20:599-604
Fletcher, Mary A; Zeng, Xiao R; Maher, Kevin et al. (2010) Biomarkers in chronic fatigue syndrome: evaluation of natural killer cell function and dipeptidyl peptidase IV/CD26. PLoS One 5:e10817
Levis, Silvina; Strickman-Stein, Nancy; Doerge, Daniel R et al. (2010) Design and baseline characteristics of the soy phytoestrogens as replacement estrogen (SPARE) study--a clinical trial of the effects of soy isoflavones in menopausal women. Contemp Clin Trials 31:293-302
Levis, Silvina; Griebeler, Marcio L (2010) The role of soy foods in the treatment of menopausal symptoms. J Nutr 140:2318S-2321S
Lagari, Violet S; Levis, Silvina (2010) Phytoestrogens and bone health. Curr Opin Endocrinol Diabetes Obes 17:546-53
Fletcher, Mary A; Rosenthal, Martin; Antoni, Michael et al. (2010) Plasma neuropeptide Y: a biomarker for symptom severity in chronic fatigue syndrome. Behav Brain Funct 6:76
Fletcher, Mary Ann; Zeng, Xiao Rong; Barnes, Zachary et al. (2009) Plasma cytokines in women with chronic fatigue syndrome. J Transl Med 7:96