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A fiber supplement may help perimenopausal women — a trial puts it to the test

NCT ID NCT07724522

Disease control Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This trial tests whether taking inulin, a type of dietary fiber, for two weeks can improve cardiovascular health, muscle function, and the balance of gut and vaginal bacteria in perimenopausal women who are overweight or have obesity. Participants will take either inulin or a placebo for two weeks, then switch after a washout period. The study aims to see if this simple supplement can ease some health risks that rise during the menopause transition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inulin, a dietary fiber supplement
What this could lead to
If it works, this could point toward a simple dietary supplement to help manage cardiometabolic risks during the perimenopausal transition.
What could go wrong
This is a small, early-stage trial with only 27 participants and a short 2-week treatment period, so results may not apply broadly. Inulin can cause digestive discomfort in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Insulin Resistance Obesity obesity disorder Overweight skeletal muscle disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases (CVD) Dietary fiber Gastrointestinal microbiome Insulin resistance INULIN Microbiota Muscle, skeletal Obesity & overweight Perimenopausal women Prebiotics Vascular health Women health

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Milken Institute School of Public Health

    RECRUITING

    Washington D.C., District of Columbia, 20052, United States

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