Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179556
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2005-09-13
Brief Title:
Effects of Soy Isoflavones on Menopausal Hot Flashes
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Hot flashes occur in three quarters of menopausal women and can negatively impact quality of life Interest has arisen in isoflavones found in rich supply in soy products as therapy for hot flashes The study examines the effect of a new soy supplement as compared to a placebo in menopausal women on hot flash symptoms
Detailed Description:
Hot flashes occur in 75 of menopausal women and impact quality of life Interest has arisen in isoflavones found in rich supply in soy products as therapy for hot flashes The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized placebo controlled double-blinded clinical trial The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary Subjects are given 40 mg or 60 mg of isoflavones or placebo once a day This isoflavone-aglycone extract Agly-Max TM Nichimo Shinagawa Tokyo Japan is a product prepared from soybean germ fermentation with Koji fungus Aspergliius awamori producing ß-glycosidase efficiency followed by ethanol and water extraction and purification by using a proprietary extraction procedure The product is rich in daidzein 70 daidzein 10 genistein and 20 glycitein
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None