[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607902":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":28,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":28,"enrollmentInfo":72,"targetDuration":28,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":41,"whyStopped":28,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Equol","EXPERIMENTAL","This group will receive 10 mg equol per day (2 capsules\u002Fday, 5mg equol\u002Fcapsule).",[13],"Drug: Equol",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This group will receive 2 placebo capsules per day.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],[25],"Equelle",{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":28},[15],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Ester Oh, PhD","CONTACT","303-724-3765","ester.oh@cuanschutz.edu",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":28},"Emily Andrews","303-724-7790",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-104.83192,39.72943,{"lat":51,"lon":50},[54],{"name":36,"role":32,"phone":55,"phoneExt":28,"email":56},"303-724-2275","EMILY.S.ANDREWS@CUANSCHUTZ.EDU",{"type":58,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[60],{"name":61,"class":62},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100607902","phase-2-equol-and-vascular-function-in-women-with-chronic-kidney-disease-100607902",false,"NCT07194590","Equol and Vascular Function in Women With Chronic Kidney Disease","Equol Supplementation for Improving Vascular Function in Postmenopausal Women With CKD","Inclusion Criteria:\n\n* Postmenopausal women\n* Aged ≥50 years\n* CKD stage 3 or 4 (eGFR with the CKD-EPI 2021 race-free equation: 15-59 mL\u002Fmin\u002F1.73m2; stable renal function in the past 3 months)\n* Low habitual intake of soy (soy-related food intake \\\u003C 2 times per week assessed by Soy-Specific Food Frequency Questionnaire)\n* Weight stable in the prior 3 months (\\\u003C2 kg weight change) and willing to remain weight stable throughout the study\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Patients with advanced CKD requiring chronic dialysis\n* Uncontrolled hypertension in CKD group (BP \\>140\u002F90 mmHg)\n* Use of any hormone replacement therapy\n* Allergy and\u002For intolerance to soy or soy-based products\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2X upper limit of normal range (upper limit of normal range AST: 117 U\u002FL; ALT: 52 U\u002FL; total bilirubin: 1.3 mg\u002FdL)\n* History of breast cancer\n* Significant co-morbid conditions with a life expectancy of \\\u003C 1 year\n* Current tobacco or nicotine use or history of use in the last 12 months\n* History of kidney transplant\n* History of severe congestive heart failure (i.e., ejection fraction \\\u003C35%)\n* History of hospitalization within the last month\n* Immunosuppressant agents taken in the past 12 months\n* Known malignancy","FEMALE","50 Years",{"count":73,"type":74},74,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in nephrology focuses on male patients, and studies on women's vascular health are limited. Establishing effective therapies for improving vascular function and reducing CVD risk in women with CKD is a high research priority of the NIH.\n\nEquol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties. However, there is no information on the effect of equol on vascular function in women with CKD. The proposed project aims to determine the effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal women with CKD.",[80,81,82,83,84],"Chronic Kidney Disease (Stage 3-4)","Vascular Function","Cognitive Functions","Cerebrovascular Function","Blood Pressure",[86,87,88,89,81],"S-equol","Randomized Controlled Trial","Chronic Kidney Disease","Women's Health","2026-06-01",{"date":92,"type":93},"2026-06-02","ACTUAL",{"date":95,"type":93},"2026-02-19",{"date":97,"type":74},"2030-11-30",{"name":5,"class":6},1]