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NCT Number: NCT07136220

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

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.

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Key information

Conditions

Menopause

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Consumption of soy protein bar

Other

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

Primary outcomes

Urine Equol Concentration

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Seng Bin Dr Ang

CONTACT

[email protected]

+65 6394 1102

Sponsors and collaborators

Lead sponsor

Ang Seng Bin

Other Gov

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Registry information

Acronym: EQUOL

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 22, 2025
Registry last updated: Aug 22, 2025

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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