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

January 12, 2005
August 17, 2006
November 2001
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Complete list of historical versions of study NCT00101699 on ClinicalTrials.gov Archive Site
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Effects of Soy Consumption on Symptoms of Menopause
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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Menopause
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2003
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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
Female
45 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00101699
F31 AT001041-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Melissa K. Melby, MPhil, MA Emory University
National Center for Complementary and Alternative Medicine (NCCAM)
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP