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.
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;
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;
Crossover
Inulin
Dietary supplement10g per day for 2 weeks
Maltodextrin (Placebo)
Dietary supplement10g per day for 2 weeks
Change in Gut Microbiome Composition
Change in gut microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Change in Gut Microbiome Functional Capacity
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 Composition
Change in vaginal microbiome composition, assessed by shotgun metagenomic sequencing, comparing inulin versus placebo in a randomized crossover design.
Vascular Function
Change in vascular function, assessed by pulse-wave velocity (PWV), comparing inulin versus placebo in a randomized crossover design.
Metabolic Flexibility
Change in metabolic flexibility, assessed as the change in respiratory exchange ratio (RER) from the fasted resting state to the postprandial period following a standardized high-fat mixed meal, measured continuously via indirect calorimetry, comparing inulin versus placebo in a randomized crossover design.
Skeletal muscle mitochondrial oxidative capacity
Change in skeletal muscle mitochondrial oxidative capacity in the gastrocnemius muscle, comparing inulin versus placebo in a randomized crossover design. Muscle oxidative capacity will be assessed using near-infrared spectroscopy (NIRS).
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