[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648817":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":86,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"George Washington University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A (Inulin → Placebo)","EXPERIMENTAL","Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.",[13,14],"Dietary Supplement: Inulin","Dietary Supplement: Maltodextrin (Placebo)",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: Sequence B (Placebo → Inulin)","Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Inulin","10g per day for 2 weeks",[16,9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Maltodextrin (Placebo)",[16,9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Carmen Ortega-Santos, PhD, RD","CONTACT","202-994-2757","fitgutlab@gwu.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Milken Institute School of Public Health","RECRUITING","Washington D.C.","District of Columbia","20052","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-77.03637,38.89511,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Carmen Ortega-Santos","Assistant Professor","100648817","prebiotic-inulin-for-late-reproductive-individuals-100648817",false,"NCT07724522","Prebiotic Inulin for Late-Reproductive Individuals","A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women","PILI","Inclusion Criteria:\n\n* Body mass index: 25 - 40 kg\u002Fm2;\n* Menstrual cycle irregularity (cycle length outside 21 - 35 days or variation \\> 7 days) or\u002Fand ≥ 2 skipped cycles and interval of ≥ 60 days of amenorrhea; with or without hot flashes or\u002Fand night sweats;\n* Weight stable within the last 3 months (body weight fluctuations within the 5% of their habitual body weight);\n* Spending ≥ 6 hours sitting;\n* \\\u003C 150 minutes per week (50 minutes per day, 3 days per week OR 30 minutes per day, 5 days per week) of moderate to vigorous structured physical activity (i.e., planned intentional physical activity, not incidental movement).\n\nExclusion Criteria:\n\n* Recent antibiotic use oral or vaginal (≥ 6months);\n* Diagnosed with any chronic disease (e.g., any gastrointestinal condition like IBD, type 2 diabetes, or cancer);\n* Prescription of hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications, or weight loss medications\n* Smoking;\n* Recent blood donation (within the past 8-12 weeks);\n* Significant weight changes (≥5%) in the last 4 weeks;\n* Use of dietary supplements (unless discontinued 4 weeks prior);\n* Participants taking long-term, stable medications for chronic conditions such as hypertension or hyperlipidemia will not be excluded if their medication regimen has been unchanged for at least 2 years, as these treatments are part of their usual health status. Recent medication changes (within the past 6 months), initiation of new prescriptions, or use of medications known to affect metabolic, vascular, vaginal, hormonal, or gastrointestinal function will result in exclusion.\n* Fructose intolerance.","FEMALE","40 Years","55 Years",{"count":68,"type":69},27,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study aims to evaluate the effects of 2 weeks of inulin supplementation in perimenopausal women with overweight or obesity. The primary questions this study seeks to answer are:\n\n1. Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo?\n2. Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo?\n3. Does 2 weeks of inulin supplementation affect skeletal muscle health compared with placebo?\n\nResearchers will compare inulin with a placebo (a similar-looking supplement that does not contain inulin) to determine whether inulin influences gut and vaginal microbial function, cardiovascular health, and skeletal muscle health during the perimenopausal transition.\n\nParticipants will:\n\n* Take either inulin or a placebo for 2 weeks, followed by a 2- to 4-week washout period, and then switch to the other supplement for an additional 2 weeks.\n* Attend 8 study visits over approximately 12 to 16 weeks for assessments and sample collection.\n* Complete weekly phone calls to monitor symptoms, supplement adherence, and dietary intake.\n* Wear a Fitbit device throughout the study to monitor physical activity.",[75,76,77,22,78,79,80,81,82,83,84,85],"Obesity & Overweight","Perimenopausal Women","Prebiotics","Muscle, Skeletal","Cardiovascular Diseases (CVD)","Microbiota","Gastrointestinal Microbiome","Dietary Fiber","Women Health","Vascular Health","Insulin Resistance",[87,88,89,90,91,92,93,94,95,96,97,22,84],"Perimenopause","Nutrition","Menopause transition","Overweight","Obesity","Cardiometabolic Health","Vascular function","Randomized Controlled Trial","Gut microbiome","Vaginal microbiome","Supplements","2026-08-07",{"date":100,"type":101},"2026-08-11","ACTUAL",{"date":103,"type":101},"2026-08-01",{"date":105,"type":69},"2028-02",{"name":5,"class":6},1]