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Effects of Soy Isoflavones on Menopausal Hot Flashes

This study has been completed.
Nichimo - Tokyo, Japan
Information provided by (Responsible Party):
Hope Ricciotti, Beth Israel Deaconess Medical Center Identifier:
First received: September 13, 2005
Last updated: March 12, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Menopausal Symptoms
Drug: Isoflavone supplement
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Hot flash frequency and severity

Secondary Outcome Measures:
  • Menopausal quality of life

Estimated Enrollment: 210
Study Start Date: June 2003
Study Completion Date: September 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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).

Ages Eligible for Study:   38 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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Please refer to this study by its identifier: NCT00179556

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
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
  More Information

Responsible Party: Hope Ricciotti, Associate Professor of Obstetrics, Gynecology and Reproductive Biology, Beth Israel Deaconess Medical Center Identifier: NCT00179556     History of Changes
Other Study ID Numbers: 2002P000037
Study First Received: September 13, 2005
Last Updated: March 12, 2017

Keywords provided by Beth Israel Deaconess Medical Center:
Hot flashes
Menopausal symptoms
Soybean germ
Menopause processed this record on April 28, 2017