A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
George Washington University
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.
Description
This proposal presents a proof-of-concept study of the Prebiotic Inulin for Late Reproductive Individuals (PILI) intervention, a prebiotic fiber supplementation among women with perimenopause and overweight or obesity. More specifically, the PILI intervention integrates multi-omics, physiological, and cardiometabolic assessments to examine the effects of inulin supplementation on overall health during the menopausal transition. Outcomes include changes in the gut and vaginal microbiome and their functional activity, gut-derived metabolites, vascular health, metabolic flexibility, skeletal mus…