Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT07136220
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-19', 'size': 230225, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-01T03:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine Equol Concentration', 'timeFrame': 'first morning urine sample collected at baseline and first urine sample collected the morning after consuming the soy bar', 'description': 'Equol is a metabolite of isoflavone which is secreted in the urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'equol'], 'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '20671375', 'type': 'BACKGROUND', 'citation': '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': '24019393', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nPrevious 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.\n\nThis study will involve participants consuming a soy protein bar and collection of urine samples before and after its consumption.", 'detailedDescription': "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.\n\nDay 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.\n\nDay 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in Singapore aged 40-60', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women aged 40-60\n\nExclusion Criteria:\n\n* Pregnant women\n* Allergy to Soy\n* Allergy to nuts\n* Consumed antibiotics within 7 days of the study\n* Has a history of autoimmune diseases\n* Has a history of thyroid disease\n* On medical treatment with hormone therapy, elective oestrogen receptors modulators\n* Consuming equol-containing supplements or food\n* Consuming painkillers\n* Consuming anti-depressants and/or sleeping pills'}, 'identificationModule': {'nctId': 'NCT07136220', 'acronym': 'EQUOL', 'briefTitle': 'A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore', 'orgStudyIdInfo': {'id': '2025/0693'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Consumption of soy protein bar', 'type': 'OTHER', 'description': 'The participants will be provided one soy protein bar to consume after dinner on day 1.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Seng Bin Dr Ang', 'role': 'CONTACT', 'email': 'ang.seng.bin@singhealth.com.sg', 'phone': '+65 6394 1102'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ang Seng Bin', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Ang Seng Bin', 'investigatorAffiliation': "KK Women's and Children's Hospital"}}}}