A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore

NCT07136220 | Recruiting

• 1 other identifier: 2025/0693
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to evaluate the effect of equol on menopausal symptoms of women. Our hypothesis is that equol producers will have milder menopausal symptoms compared to non-equol producers. Equol is known as a metabolite produced by gut microbiota from soy-related diet and has estrogen-like activity compared to the isoflavones from soybean. Previous studies have shown that some women can produce equol from soy-related diet, but the others cannot because they don't have the bacteria which can metabolite daidzein in gut even if they take isoflavones thorough soybean products. This study will involve participants consuming a soy protein bar and collection of urine samples before and after its consumption.

Conditions

Menopause

Keywords

menopause; equol

Outcome Measures

Primary Outcomes (1)

• Urine Equol Concentration

  Equol is a metabolite of isoflavone which is secreted in the urine

  first morning urine sample collected at baseline and first urine sample collected the morning after consuming the soy bar

Interventions

Consumption of soy protein bar OTHER

The participants will be provided one soy protein bar to consume after dinner on day 1.

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in Singapore aged 40-60

You may qualify if:

• \- Women aged 40-60

You may not qualify if:

• 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

Sponsors & Collaborators

• Ang Seng Bin: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related Publications (2)

• Liu B, Qin L, Liu A, Uchiyama S, Ueno T, Li X, Wang P. Prevalence of the equol-producer phenotype and its relationship with dietary isoflavone and serum lipids in healthy Chinese adults. J Epidemiol. 2010;20(5):377-84. doi: 10.2188/jea.je20090185. Epub 2010 Jul 24.

  PMID: 20671375 BACKGROUND

• Tseng M, Byrne C, Kurzer MS, Fang CY. Equol-producing status, isoflavone intake, and breast density in a sample of U.S. Chinese women. Cancer Epidemiol Biomarkers Prev. 2013 Nov;22(11):1975-83. doi: 10.1158/1055-9965.EPI-13-0593. Epub 2013 Sep 9.

  PMID: 24019393 BACKGROUND

Central Study Contacts

Seng Bin Dr Ang

CONTACT

+65 6394 1102; ang.seng.bin@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: July 2, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)