Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age40 Years to 55 Years
SexFemale
Healthy volunteersNot accepted
ConditionObesity & Overweight, Perimenopausal Women, Prebiotics, Inulin, Muscle, Skeletal, Cardiovascular Diseases (CVD), Microbiota, Gastrointestinal Microbiome, Dietary Fiber, Women Health, Vascular Health, Insulin Resistance
Full registry criteria
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.
Primary outcomes
Change in Gut Microbiome CompositionBaseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).Change in gut microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Change in Gut Microbiome Functional CapacityBaseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).Change in gut microbiome functional capacity, including biosynthetic gene clusters (BGCs) and estrobolome-related microbial pathways, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Change in Vaginal Microbiome CompositionBaseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).Change in vaginal microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
