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Effects of Soy Consumption on Symptoms of Menopause - Article


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Clinical Trial: Effects of Soy Consumption on Symptoms of Menopause

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to examine the way soy consumption affects menopausal symptoms in middle-aged Japanese women.

Condition
Menopause

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Influence of Soy Consumption on Menopause

Further Study Details: 

Expected Total Enrollment:  120

Study start: November 2001;  Study completion: May 2006
Last follow-up: August 2003;  Data entry closure: August 2003

For the past 20 years, Japanese women have reported fewer menopausal symptoms than their North American counterparts. One explanation for the disparity is the differences in diet. Evidence suggests that Japanese women consume large amounts of soy, a phytoestrogen that is structurally similar to the hormone estrogen. However, there is a lack of menopause-related research data from non-Western populations. This study will be a long-term observation of the effects of soy consumption in menopausal Japanese women.

This study will last 6 months. Participants will complete a dietary log and a menopausal symptom checklist daily. There will be three or four study visits. During these visits, participants will complete a diet questionnaire, have a blood sample collected, and be interviewed about their menopausal symptoms. Six months after study completion, participants will be sent a questionnaire about any recent menopausal symptoms they may have experienced.

Eligibility

Ages Eligible for Study:  45 Years   -   55 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Japanese resident
  • Menopausal

Exclusion Criteria:

  • Hysterectomy, removal of ovaries, or tubal ligation with subsequent menstrual changes
  • Hormones for menopause or birth control pills within 5 years of study entry
  • Recent major illness
  • Medication that could affect naturally-produced hormones

Location Information


Japan, Fukushima
      Loma Linda Clinic, Koriyama,  Fukushima,  963-8002,  Japan

Japan, Kyoto
      Kyoto Prefectural University of Medicine, Kamigyo-ku,  Kyoto,  602-8566,  Japan

Study chairs or principal investigators

Melissa K. Melby, MPhil, MA,  Principal Investigator,  Emory University   

More Information

Study ID Numbers:  1-F31-AT001041-01
Record last reviewed:  January 2005
Last Updated:  January 12, 2005
Record first received:  January 12, 2005
ClinicalTrials.gov Identifier:  NCT00101699
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources

  • (National Women's Health Information Center, OWH, HHS)
  • (National Women's Health Information Center, OWH, HHS)


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December 1, 2009



Page Updated: October 15, 2009
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