Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118846
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2005-07-07
Brief Title:
Womens Isoflavone Soy Health WISH Trial
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phytoestrogens and Progression of Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women
Detailed Description:
Heart disease is the leading cause of death among women in the United States Atherosclerosis a primary cause of heart disease accounts for more than 485000 heart attacks and 370000 strokes each year in American women Data indicate that a womans risk of suffering from an atherosclerosis-related cardiovascular event significantly increases after menopause this risk may be due to reduced estrogen production associated with menopause Soy isoflavones are plant compounds that are structurally similar to human estrogen Evidence suggests that soy supplements may provide the same protection against heart disease as estrogen in postmenopausal women This study will determine the effects of soy supplementation on subclinical atherosclerosis progression and cognitive decline in postmenopausal women
In this double-blinded placebo-controlled trial a total of 350 postmenopausal women were randomly assigned to receive either soy protein supplementation or placebo twice daily for 27 years The initial 25-year treatment period was increased to 3 years The active product given as two divided doses was 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones 150 mg total isoflavone of genistein 45 mg aglycone weight 80 mg total weight daidzein 35 mg aglycone weight 60 mg total weight and glycitein 5 mg aglycone weight 10 mg total weight The primary trial end point was the rate of change in the right distal common carotid artery intima-media thickness CIMT by ultrasonography Participants underwent ultrasonography at baseline and every six months along with laboratory determinations and clinical measurements Cognitive assessments were completed at baseline and the final follow-up visit 25 years
In this double-blinded placebo-controlled trial a total of 350 postmenopausal women were randomly assigned to receive either soy protein supplementation or placebo twice daily for 27 years The initial 25-year treatment period was increased to 3 years The active product given as two divided doses was 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones 150 mg total isoflavone of genistein 45 mg aglycone weight 80 mg total weight daidzein 35 mg aglycone weight 60 mg total weight and glycitein 5 mg aglycone weight 10 mg total weight The primary trial end point was the rate of change in the right distal common carotid artery intima-media thickness CIMT by ultrasonography Participants underwent ultrasonography at baseline and every six months along with laboratory determinations and clinical measurements Cognitive assessments were completed at baseline and the final follow-up visit 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AT001653-02S5 | NIH | None | httpsreporternihgovquickSearchU01AT001653-02S5 |
| U01AT001653 | NIH | None | None |
| U01AT001653-02S2 | NIH | None | None |
| U01AT001653-02S4 | NIH | None | None |