Prebiotic Inulin for Late-Reproductive Individuals (P.I.L.I. study): A Protocol for a Placebo-Blind, Cross-Over Randomized Controlled Trial

In a placebo-blind crossover trial in 27 perimenopausal overweight women or with obesity aged 40–55, 10 g/day inulin for 14 days will be tested for gut and microbial metabolite effects.

• Why it matters: Perimenopause involves hormonal fluctuations that may raise cardiometabolic risk, and the gut microbiome could mediate changes via estrogen metabolism and microbial metabolites.
• What they did: Participants will complete two 14-day periods of 10 g/day inulin versus matched maltodextrin placebo, separated by a 2–4-week washout, with primary outcomes including gut and vaginal microbiome and stool/plasma microbial metabolites plus estrogen-metabolism markers.
• The result: The protocol will generate proof-of-concept evidence on feasibility, adherence, tolerability, and biological effects on gut-host mechanisms, vascular function, skeletal muscle health, and metabolic flexibility to guide larger trials.

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