[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inulin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inulin":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":5},"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":21,"type":22},27,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34,35,36,37,38,39],"Obesity & Overweight","Perimenopausal Women","Prebiotics","Inulin","Muscle, Skeletal","Cardiovascular Diseases (CVD)","Microbiota","Gastrointestinal Microbiome","Dietary Fiber","Women Health","Vascular Health","Insulin Resistance",[41,42,43,44,45,46,47,48,49,50,51,31,38],"Perimenopause","Nutrition","Menopause transition","Overweight","Obesity","Cardiometabolic Health","Vascular function","Randomized Controlled Trial","Gut microbiome","Vaginal microbiome","Supplements","RECRUITING","2026-08-07",{"date":55,"type":56},"2026-08-11","ACTUAL",{"date":58,"type":56},"2026-08-01",{"date":60,"type":22},"2028-02",{"name":62,"class":63},"George Washington University","OTHER"]