Effects of Soy Consumption on Symptoms of Menopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Women Soy Foods Middle Aged

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa K. Melby, MPhil, MA

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda Clinic

Kōriyama, Fukushima, Japan

Site Status

Kyoto Prefectural University of Medicine

Kamigyō-ku, Kyoto, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F31AT001041-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link