CVD Risk and Health in Postmenopausal Phytoestrogen Users
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|ClinicalTrials.gov Identifier: NCT00000613|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bone Diseases Cardiovascular Diseases Coronary Disease Depression Heart Diseases Myocardial Ischemia Osteoporosis Postmenopause||Behavioral: dietary supplements Drug: genistein Behavioral: diet, soy proteins||Phase 2|
Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density. However, a large proportion of postmenopausal women are not compliant with therapeutic regimens. Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects, and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women. However, few intervention trials have examined the extent to which it is possible to improve heart disease risk factors, bone density, and quality of life in postmenopausal women through use of a dietary supplement of phytoestrogen.
Randomized, double-blind, placebo-controlled study. A total of 210 women were enrolled in the study to be followed for one to two years. The women were randomized to phytoestrogen treatment or to placebo. Data are collected at baseline visits, at one and three month follow-up telephone calls, and at 6, 12, and 24 month follow-up clinic visits. Measures of high density lipoprotein and other heart disease risk factors, hip and spine bone density, and depression, life satisfaction, and quality of well-being are obtained. Cross-sectional and longitudinal comparisons of treatment and placebo groups are performed before and after adjustment and stratification for potentially confounding covariates.
The study was renewed in March 2002 to assess whether the women treated with phytoestrogens had lowered homocysteine, interleukin-6, C-reactive protein, E-selectin, and decreased obesity and fat mass over two years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||April 1997|
|Actual Study Completion Date :||December 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000613
|OverallOfficial:||Donna Kritz-Silverstein||University of California, San Diego|