NCT00179556

Effects of Soy Isoflavones on Menopausal Hot Flashes

Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 38 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Menopausal Symptoms

Interventions

Type	Name	Description
DRUG	Isoflavone supplement

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-07-01
• Completion: 2005-09-01
• First posted: 2005-09-16
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States