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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

Who can join

Ages 40 to 55 · Women

Inclusion Criteria:

* Body mass index: 25 - 40 kg/m2;
* Menstrual cycle irregularity (cycle length outside 21 - 35 days or variation \> 7 days) or/and ≥ 2 skipped cycles and interval of ≥ 60 days of amenorrhea; with or without hot flashes or/and night sweats;
* Weight stable within the last 3 months (body weight fluctuations within the 5% of their habitual body weight);
* Spending ≥ 6 hours sitting;
* \< 150 minutes per week (50 minutes per day, 3 days per week OR 30 minutes per day, 5 days per week) of moderate to vigorous structured physical activity (i.e., planned intentional physical activity, not incidental movement).

Exclusion Criteria:

* Recent antibiotic use oral or vaginal (≥ 6months);
* Diagnosed with any chronic disease (e.g., any gastrointestinal condition like IBD, type 2 diabetes, or cancer);
* Prescription of hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications, or weight loss medications
* Smoking;
* Recent blood donation (within the past 8-12 weeks);
* Significant weight changes (≥5%) in the last 4 weeks;
* Use of dietary supplements (unless discontinued 4 weeks prior);
* Participants taking long-term, stable medications for chronic conditions such as hypertension or hyperlipidemia will not be excluded if their medication regimen has been unchanged for at least 2 years, as these treatments are part of their usual health status. Recent medication changes (within the past 6 months), initiation of new prescriptions, or use of medications known to affect metabolic, vascular, vaginal, hormonal, or gastrointestinal function will result in exclusion.
* Fructose intolerance.

About the study

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.

What is being tested

• Inulin (dietary supplement)
• Maltodextrin (Placebo) (dietary supplement)

Sponsor: George Washington University · Participants: 27 · Started: Aug 1, 2026

Contact the study team

• Carmen Ortega-Santos, PhD, RD · Phone: 202-994-2757

Official record on ClinicalTrials.gov — NCT07724522

Locations in the U.S.

Conditions

• Obesity
• Overweight
• Cardiovascular Disease
• Insulin Resistance

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.