deltatrials
Completed OBSERVATIONAL NCT00101699

Effects of Soy Consumption on Symptoms of Menopause

Influence of Soy Consumption on Menopause

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Conditions Menopause
Updated 7 times since 2017 Last updated: Aug 17, 2006 Started: Nov 30, 2001 Completion: Aug 31, 2003
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00101699, this observational or N/A phase trial focuses on Menopause and remains completed. Sponsored by National Center for Complementary and Integrative Health (NCCIH), it has been updated 7 times since 2001, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed

  2. Sep 2024 — Sep 2025 [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. Jun 2018 — Jan 2021 [monthly]

    Completed

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Nov 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Center for Complementary and Integrative Health (NCCIH)
Data source: National Center for Complementary and Integrative Health (NCCIH)

For direct contact, visit the study record on ClinicalTrials.gov .