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Effects of Soy Isoflavones on Menopausal Hot Flashes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179556
First Posted: September 16, 2005
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nichimo - Tokyo, Japan
Information provided by (Responsible Party):
Hope Ricciotti, Beth Israel Deaconess Medical Center
September 13, 2005
September 16, 2005
March 14, 2017
June 2003
July 2005   (Final data collection date for primary outcome measure)
Hot flash frequency and severity
Same as current
Complete list of historical versions of study NCT00179556 on ClinicalTrials.gov Archive Site
Menopausal quality of life
Same as current
Not Provided
Not Provided
 
Effects of Soy Isoflavones on Menopausal Hot Flashes
Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
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.
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).
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Menopausal Symptoms
Drug: Isoflavone supplement
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
September 2005
July 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65

Exclusion Criteria:

Pregnant, BMI>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days

Sexes Eligible for Study: Female
38 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00179556
2002P000037
Not Provided
Not Provided
Not Provided
Hope Ricciotti, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Nichimo - Tokyo, Japan
Principal Investigator: Hope Ricciotti, MD Beth Israel Deaconess Medical Center
Study Chair: George Blackburn, MD, PhD Beth Israel Deaconess Medical Center
Study Director: Lalita Khaodhiar, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP