Menopause |
Hot Flashes |
Clinical Trial: Effects of Soy Consumption on Symptoms of Menopause
This study has been completed.
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Purpose
The purpose of this study is to examine the way soy consumption affects menopausal symptoms in middle-aged Japanese women.
| Condition |
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| Menopause |
MedlinePlus consumer health information
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Influence of Soy Consumption on Menopause
Expected Total Enrollment: 120
Study start: November 2001; Study completion: May 2006
Last follow-up: August 2003; Data entry closure: 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 - 55 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
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
Location Information
Japan, Fukushima
Loma Linda Clinic, Koriyama, Fukushima, 963-8002, Japan
Japan, Kyoto
Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, 602-8566, Japan
Melissa K. Melby, MPhil, MA, Principal Investigator, Emory University
More Information
Record last reviewed: January 2005
Last Updated: January 12, 2005
Record first received: January 12, 2005
ClinicalTrials.gov Identifier: NCT00101699
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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