Healia Clinical Trials Information Database

Influence of Soy Consumption on Menopause

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

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.

Status: Completed (N/A). Started on November 1st, 2001. Ended on August 1st, 2003.

Enrollment: 120 subjects

Study Type: Observational

Study Design:

  • Natural History
  • Longitudinal
  • Defined Population
  • Prospective Study

Conditions:

Interventions:


Eligibility

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

Gender

Female

Mininum Age

45 Years

Maximum Age

55 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: National Center for Complementary and Alternative Medicine (NCCAM)

Authority: United States: Federal Government

Locations

  • Loma Linda Clinic
    Koriyama
    Fukushima
    963-8002
    Japan
  • Kyoto Prefectural University of Medicine
    Kamigyo-ku
    Kyoto
    602-8566
    Japan

Officials

  • Melissa K. Melby, MPhil, MA (Principal Investigator, Emory University)

Sponsors

  • National Center for Complementary and Alternative Medicine (NCCAM) (Lead Sponsor)

References

None.

Links

None.


Date Verified
January 1st, 2005
First Received
August 17th, 2006
Last Changed
August 17th, 2006

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


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The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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