Study of Daily Inulin Supplement Compared to Placebo to Improve Gut, Vaginal Microbiome and Cardiovascular Health in Perimenopausal Women with Overweight or Obesity

What this Trial Is About

Researchers are studying the effects of a 2-week inulin supplement compared with a placebo in perimenopausal women aged 40 to 55 who have overweight or obesity. The study aims to find out if inulin changes the gut and vaginal microbiome, and whether it impacts cardiovascular and skeletal muscle health during this stage. This is a proof-of-concept trial integrating multiple biological, physiological, and cardiometabolic assessments to advance understanding of health during the menopausal transition. Participants will be randomly assigned to take either inulin or a placebo daily for 2 weeks, followed by a 2- to 4-week washout period, then switch to the other supplement for another 2 weeks. This crossover design lets each participant serve as her own control. The inulin and placebo doses are each 10 grams per day. Throughout the study, participants attend scheduled in-person visits before and after each intervention period for sample collection and clinical tests. During the approximately 12 to 16-week study, participants will attend 8 visits for assessments including blood, stool, and vaginal samples, body composition, vascular and metabolic testing, muscle function, and questionnaires on diet, activity, sleep, and menopausal symptoms. They will wear a Fitbit device to monitor physical activity and sleep continuously, and receive weekly calls to check symptoms, adherence, and diet. The study will measure changes in gut and vaginal microbiome composition and function, vascular health, metabolic flexibility, and skeletal muscle capacity, while also evaluating feasibility and participant experience.

Prebiotic Inulin for Late-Reproductive Individuals