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Effects of Soy Isoflavones on Menopausal Hot Flashes

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ClinicalTrials.gov Identifier: NCT00179556
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Nichimo - Tokyo, Japan
Information provided by (Responsible Party):
Hope Ricciotti, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Menopausal Symptoms Drug: Isoflavone supplement Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
Study Start Date : June 2003
Primary Completion Date : July 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources




Primary Outcome Measures :
  1. Hot flash frequency and severity

Secondary Outcome Measures :
  1. Menopausal quality of life


Information from the National Library of Medicine

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179556


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Nichimo - Tokyo, Japan
Investigators
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

Responsible Party: Hope Ricciotti, Associate Professor of Obstetrics, Gynecology and Reproductive Biology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179556     History of Changes
Other Study ID Numbers: 2002P000037
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Hope Ricciotti, Beth Israel Deaconess Medical Center:
Hot flashes
Menopausal symptoms
Soybean germ
Aglycones
Menopause