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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00101699 |
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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | 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 to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan | |
| Loma Linda Clinic | |
| Koriyama, Fukushima, Japan, 963-8002 | |
| Kyoto Prefectural University of Medicine | |
| Kamigyo-ku, Kyoto, Japan, 602-8566 | |
| Principal Investigator: | Melissa K. Melby, MPhil, MA | Emory University |
More Information
| 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 |
|
Women Soy Foods Middle Aged |