Equol's effect on menopausal symptoms in Singaporean women
A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore
This project will test if making equol after eating a soy protein bar helps lessen menopausal symptoms in Singaporean women aged 40–60.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07136220 on ClinicalTrials.gov |
What this trial studies
Women aged 40–60 will complete questionnaires on menopausal and vulvovaginal symptoms, diet, and physical activity and have basic vitals measured. Participants will provide a first-morning urine sample, eat a provided soy protein bar after dinner, and provide a second first-morning urine sample the next day; samples are frozen at KK Women's and Children's Hospital and batch-shipped to a laboratory in Japan for urinary equol analysis. The study compares symptom scores between women who produce equol after soy intake and those who do not. Key exclusions include pregnancy, soy or nut allergy, recent antibiotic use, autoimmune or thyroid disease, hormone therapy, and certain medications.
Who should consider this trial
Good fit: Women aged 40–60 in Singapore who are not pregnant, not allergic to soy or nuts, not taking hormone therapy or excluded medications, and who have not used antibiotics in the past week.
Not a fit: Women who are pregnant, allergic to soy or nuts, on hormone therapy or certain excluded medications, recent antibiotic users, or with autoimmune or thyroid disease are excluded and would not benefit from participating.
Why it matters
Potential benefit: If equol production is linked to milder symptoms, identifying equol-producers or targeting equol through diet or supplements could help personalize care for menopausal symptoms.
How similar studies have performed: Previous research shows some women can produce equol from soy and that equol or equol-producing status has reduced menopausal symptoms in some studies, but results across trials have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Women aged 40-60 Exclusion Criteria: * Pregnant women * Allergy to Soy * Allergy to nuts * Consumed antibiotics within 7 days of the study * Has a history of autoimmune diseases * Has a history of thyroid disease * On medical treatment with hormone therapy, elective oestrogen receptors modulators * Consuming equol-containing supplements or food * Consuming painkillers * Consuming anti-depressants and/or sleeping pills
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Seng Bin Dr Ang
- Email: ang.seng.bin@singhealth.com.sg
- Phone: +65 6394 1102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.