A Pilot Study to Evaluate Equol and Its Effects on Menopa... | NCT07136220

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

NCT07136220

Sponsor

Ang Seng Bin

Status

Recruiting

Last Update Posted

Aug 22, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Menopause

Interventions

Consumption of soy protein bar

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2025Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 8, 2025

First Submission Date that Met QC Criteria

Aug 14, 2025

First Posted Date

Aug 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2025

Last Update Posted Date

Aug 22, 2025Actual

Name	Class
Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Consumption of soy protein bar	Other	The participants will be provided one soy protein bar to consume after dinner on day 1.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Women in Singapore aged 40-60

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seng Bin Dr Ang	Contact	+65 6394 1102		ang.seng.bin@singhealth.com.sg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital	Recruiting	Singapore			Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20671375	Background	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.
24019393	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.