Clinical trial NCT00000613: CVD Risk and Health in Postmenopausal Phytoestrogen Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Diseases
Cardiovascular Diseases
Coronary Disease
Depression
Heart Diseases
Myocardial Ischemia
Osteoporosis
Postmenopause
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the acceptability and benefits of use of a dietary supplement of the phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and psychosocial outcomes in postmenopausal women.

Detailed description: BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Eligibility criteria: Postmenopausal women, ages 45 to 74.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Donna Kritz-Silverstein
References:
citation: Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202.
citation: Kritz-Silverstein D, Goodman-Gruen DL. Usual dietary isoflavone intake, bone mineral density, and bone metabolism in postmenopausal women. J Womens Health Gend Based Med. 2002 Jan-Feb;11(1):69-78. doi: 10.1089/152460902753473480.
citation: Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake and body composition in postmenopausal women. Menopause. 2003 Sep-Oct;10(5):427-32. doi: 10.1097/01.GME.0000058866.35869.B4.