Effects of Soy Isoflavones on Menopausal Hot Flashes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Nichimo - Tokyo, Japan
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179556
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Estimated Study Completion Date: September 2005
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).

  Eligibility

Ages Eligible for Study:   38 Years to 65 Years
Genders 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179556     History of Changes
Other Study ID Numbers: 2002P-000037
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014