Clinical Research Directory
Browse clinical research sites, groups, and studies.
Prebiotic Inulin for Late-Reproductive Individuals
Sponsor: 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.
Official title: A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
Key Details
Gender
FEMALE
Age Range
40 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2026-08-01
Completion Date
2028-02
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
Inulin
10g per day for 2 weeks
Maltodextrin (Placebo)
10g per day for 2 weeks
Locations (1)
Milken Institute School of Public Health
Washington D.C., District of Columbia, United States