Status
Recruiting
Phase
N/A
Study type
Observational
Enrollment
300
Sex
Women only
Ages
Ages 40 Years to 60 Years
Primary completion
2025-12
Last update
2025-08-22

What this trial studies

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.

Conditions in scope

  • Menopause

Interventions

  • Consumption of soy protein bar (Other) — The participants will be provided one soy protein bar to consume after dinner on day 1.

Who can join

Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Singapore KK Women's and Children's Hospital Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Observational
  • Phase: N/A
  • Start date: 2025-07-02
  • Primary completion: 2025-12
  • Last update posted: 2025-08-22
  • First posted: 2025-08-22

Lead sponsor: Ang Seng Bin (Other Gov)

Collaborators: Otsuka Pharmaceutical Co., Ltd.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Urine Equol Concentration (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

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07136220 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.