RecruitingNot ApplicableNCT07724522

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


Sponsor

George Washington University

Enrollment

27 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Inulin and Maltodextrin (Placebo) for people with cardiovascular diseases (cvd), dietary fiber, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTInulin

10g per day for 2 weeks

DIETARY_SUPPLEMENTMaltodextrin (Placebo)

10g per day for 2 weeks


Locations(1)

Milken Institute School of Public Health

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

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NCT07724522


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