A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Consumption of soy protein bar.
- Who it may be relevant to
- Registry conditions: Menopause. Basic parameters: 40 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Day 0 - Recruitment and consent taking. Height, weight and blood pressure would be measured. Patients will also fill up questionnaires on basic demographics, menopausal symptoms (Menopause Rating Scale and Vulvovaginal Symptom Questionnaire), Food Frequency Questionnaire for Soy intake, International Physical Activity Questionnaire.
Day 1 - Collect first morning urine between 5ml to 10 ml in the pre-labelled (will not contain identifiers but only assigned study subject number) containers provided. Store the urine sample in cool place in room temperature and dispatch to site after the second sample has been collected. To consume a soy based protein bar provided by study after dinner on day 1.
Day 2 - Collect first morning urine between 5ml to 10 ml in the pre-labelled(will not contain identifiers but only assigned study subject number) containers provided. Double bag the containers and call courier to dispatch urine to KK Women's and Children's Hospital.
All urine samples received will be immediately frozen and stored in KKH in a freezer. The samples will be couriered to Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co. Ltd, Japan in batches for analysis of urinary equol concentration. Clinical Trials Agreement has been executed between Otsuka Pharmaceutical Co. Ltd, Japan and KK Women's and Children's Hospital.
Interventions
- Other Consumption of soy protein bar
The participants will be provided one soy protein bar to consume after dinner on day 1.
Primary outcome measures
- Urine Equol Concentration [Time frame: first morning urine sample collected at baseline and first urine sample collected the morning after consuming the soy bar]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Singapore · 1 center
- KK Women's and Children's Hospital — Singapore
Publications
- 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
- 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
Identifiers
NCT: NCT07136220 · 2025/0693