Prebiotic Inulin for Late-Reproductive Individuals

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Obesity & Overweight, Perimenopausal Women, Prebiotics, Inulin, Muscle, Skeletal, Cardiovascular Diseases (CVD), Microbiota, Gastrointestinal Microbiome, Dietary Fiber, Women Health, Vascular Health, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT07724522

Run by

George Washington University

People needed

27

Starts

2026-07-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-24

Who can join

Age: 40 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Milken Institute School of Public Health — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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