Prebiotic Inulin for Late-Reproductive Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorGeorge Washington University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Inulin
  • Maltodextrin (Placebo)

Treatment groups

27 Participants
are divided into 2 treatment groups

Sponsors and collaborators