Inulin for Women's Health
(PILI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for perimenopausal women who are overweight or obese, have irregular periods, sit at least 6 hours a day, and do less than 150 minutes of exercise weekly. Participants must be weight stable and not have chronic diseases like diabetes or IBD. Recent use of certain medications, supplements, antibiotics, or smoking excludes participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either inulin or placebo daily for 2 weeks
Washout
Participants undergo a washout period to clear the effects of the first treatment
Treatment Period 2
Participants switch to the other supplement (inulin or placebo) for 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inulin
Trial Overview
The study tests whether taking inulin (a prebiotic fiber) for two weeks affects gut bacteria, vaginal health, heart health, and muscle health compared to a placebo. Each participant tries both inulin and placebo during the study using a crossover design.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.
Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor
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