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Effects of Soy Consumption on Symptoms of Menopause

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00101699
First received: January 12, 2005
Last updated: August 17, 2006
Last verified: January 2005
History of Changes
  Purpose

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


Condition
Menopause

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Influence of Soy Consumption on Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 120
Study Start Date: November 2001
Estimated Study Completion Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101699

Locations
Japan
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 Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Melissa K. Melby, MPhil, MA Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00101699     History of Changes
Other Study ID Numbers: F31 AT001041-01
Study First Received: January 12, 2005
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Women
Soy Foods
Middle Aged

ClinicalTrials.gov processed this record on May 23, 2013