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RECRUITING
NCT07724522
NA

Prebiotic Inulin for Late-Reproductive Individuals

Sponsor: George Washington University

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Inulin

10g per day for 2 weeks

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

10g per day for 2 weeks

Locations (1)

Milken Institute School of Public Health

Washington D.C., District of Columbia, United States