Inulin Prebiotic for Perimenopausal Women with Overweight or Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, blinded crossover study in women aged 40–55 with overweight or obesity during the perimenopausal transition. Participants receive inulin and a placebo for two 2-week periods, separated by a 2–4 week washout, with each participant serving as her own control. The study uses multi-omics, cardiometabolic, and physiological assessments to explore effects on the gut and vaginal microbiomes, gut-derived metabolites, vascular health, metabolic flexibility, and skeletal muscle oxidative capacity. Primary questions focus on changes in the estrobolome, cardiovascular markers, and skeletal muscle health compared with placebo. Visits include biological sampling (blood, stool, vaginal swabs) and comprehensive clinical assessments over roughly 12–16 weeks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Milken Institute School of Public Health
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Carmen Ortega-Santos, PhD, RD
• Email: fitgutlab@gwu.edu
• Phone: 202-994-2757

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.