Effects of Soy Consumption on Symptoms of Menopause

Menopause Clinical Trial

Official title:

Influence of Soy Consumption on Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101699
• Other study ID #: F31AT001041-01
• Status: Completed
• Phase: N/A
• First received: January 12, 2005
• Last updated: August 17, 2006
• Start date: November 2001
• Est. completion date: August 2003

Study information

• Verified date: January 2005
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Menopause

Locations

Country	Name	City	State
Japan	Kyoto Prefectural University of Medicine	Kamigyo-ku	Kyoto
Japan	Loma Linda Clinic	Koriyama	Fukushima

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

Japan,