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Prebiotic Inulin for Late-Reproductive Individuals

RecruitingNAAges 40 Years - 55 YearsFemaleGeorge Washington University
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In plain words

What the trial is, and whether it could suit you

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 fo

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Body mass index: 25 - 40 kg/m2; * Menstrual cycle irregularity (cycle length outside 21 - 35 days or variation \> 7 days) or/and โ‰ฅ 2 skipped cycles and interval of โ‰ฅ 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 โ‰ฅ 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 (โ‰ฅ 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 (โ‰ฅ5%) 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.
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What it tests

  • Inulin
  • Maltodextrin (Placebo)
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Where

1 site
Milken Institute School of Public Health
Washington D.C., United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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