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Effects of Soy Consumption on Symptoms of Menopause

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ClinicalTrials.gov Identifier: NCT00101699
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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

Condition or disease

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Influence of Soy Consumption on Menopause
Study Start Date : November 2001
Estimated Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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): NCT00101699

Loma Linda Clinic
Koriyama, Fukushima, Japan, 963-8002
Kyoto Prefectural University of Medicine
Kamigyo-ku, Kyoto, Japan, 602-8566
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Melissa K. Melby, MPhil, MA Emory University

ClinicalTrials.gov Identifier: NCT00101699     History of Changes
Other Study ID Numbers: F31AT001041-01 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: January 2005

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Soy Foods
Middle Aged