Clinical Trial

Prebiotic Inulin for Late-Reproductive Individuals

Study acronym: PILI
Recruiting
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Summary
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: 1. Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo? 2. Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo? 3. Does 2 weeks of inulin supplementation affect skeletal muscle health compared with placebo? Researchers 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. Participants will: * 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. * Attend 8 study visits over approximately 12 to 16 weeks for assessments and sample collection. * Complete weekly phone calls to monitor symptoms, supplement adherence, and dietary intake. * Wear a Fitbit device throughout the study to monitor physical activity.
Trial Details
NCT Number NCT07724522
Lead Sponsor George Washington University
Conditions Obesity & Overweight, Perimenopausal Women, Prebiotics, Inulin, Muscle, Skeletal, Cardiovascular Diseases (CVD), Microbiota, Gastrointestinal Microbiome +4 more
Enrollment 27 participants
Start Date 2026-08-01
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-11