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Inulin Supplementation for Perimenopausal Women with Overweight or Obesity

This study is looking at how a prebiotic called inulin affects women aged 40-55 who are going through perimenopause and are overweight or have obesity. Researchers want to see if taking 10g of inulin daily for two weeks changes the bacteria in your gut and vagina, and if it impacts your heart health and muscle health. You would take inulin and a placebo (an inactive substance that looks the same) at different times. The main goal is to understand if inulin can improve these health areas during this life stage. The study plans to enroll 27 participants, but its current status is unclear.

Study design
This is a randomized, blinded crossover study involving 27 participants. Each participant will receive both inulin and a placebo, serving as their own control.
What's involved
You would take a daily supplement for two separate two-week periods, with a break in between. You will also attend scheduled in-person research visits before and after each intervention period.
Compensation
Not stated in the trial record.
Follow-up
Your gut and vaginal microbiome will be measured at baseline, after each two-week intervention, and after a 2-4 week washout period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07724522

Prebiotic Inulin for Late-Reproductive Individuals

Recruiting
NAAges 40–55InterventionalPrevention
George Washington University
~27 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:InulinMaltodextrin (Placebo)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Gut Microbiome Composition
Measured over Baseline, end of each 2-week intervention period (inulin and placebo), and after washout period (2-4 weeks).
+2 more outcomes measured

Conditions

Obesity & Overweight
Perimenopausal Women
Prebiotics
Inulin
Muscle, Skeletal
Cardiovascular Diseases (CVD)
Microbiota
Gastrointestinal Microbiome
Dietary Fiber
Women Health
Vascular Health
Insulin Resistance

Explore related trials

Insulin ResistanceObesityOverweightPerimenopausal

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Carmen Ortega-Santos, PhD, RD
[email protected]
202-994-2757
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.