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Completed

NCT Number: NCT00101699

Effects of Soy Consumption on Symptoms of Menopause

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

Completed

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Key information

Conditions

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Loma Linda Clinic, Kōriyama, Fukushima, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

Influence of Soy Consumption on Menopause

Important dates

Study start
2001
Study completion
2003
First posted
Jan 13, 2005
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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