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Inulin supplement for gut, heart and muscle health in perimenopausal women with overweight

Tests inulin against placebo in perimenopausal women with overweight or obesity.

Key facts

Who runs it
George Washington University
Where
Washington D.C., United StatesSee the site
Trial code
Registry title
Prebiotic Inulin for Late-Reproductive Individuals
Status
Recruiting
People taking part
27 people, planned
Started
1 Aug 2026
Expected to end
Feb 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Inulin
  • Maltodextrin (Placebo)
Record updated
11 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 40 to 55 in the perimenopausal transition who have overweight or obesity. It tests 2 weeks of inulin against a placebo.

Age
40 to 55 years
Sex
Women only
Disease stage
Perimenopausal transition with irregular menstrual cycles or skipped cycles, with or without hot flashes or night sweats. Body mass index 25 - 40 kg/m2.
Earlier treatment
No oral or vaginal antibiotics in the last 6 months. No hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications or weight loss medications. No dietary supplements unless stopped 4 weeks before.

Main reasons for not taking part

  • Any chronic disease such as a gut condition like IBD, type 2 diabetes or cancer
  • Smoking
  • Fructose intolerance
  • Blood donation in the past 8-12 weeks
  • Weight change of 5% or more in the last 4 weeks

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Prescription of hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications, or weight loss medications
  • Use of dietary supplements (unless discontinued 4 weeks prior)
  • Diagnosed with any chronic disease (e.g., any gastrointestinal condition like IBD, type 2 diabetes, or cancer)
  • 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
  • Recent antibiotic use oral or vaginal (≥ 6months)
  • Smoking
  • Recent blood donation (within the past 8-12 weeks)
  • Significant weight changes (≥5%) in the last 4 weeks
  • Fructose intolerance

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 55 years old?

Where in United States

  • Milken Institute School of Public HealthWashington D.C., United StatesContact: Carmen Ortega-Santos, PhD, RDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Sequence A (Inulin → Placebo)Treatment being tested

    Participants receive inulin daily for 2 weeks, followed by a 2-4 week washout period, then placebo for 2 weeks.

    Treatment: Inulin and Maltodextrin (Placebo)

  • Arm 2: Sequence B (Placebo → Inulin)Treatment being tested

    Participants receive a placebo daily for 2 weeks, followed by a 2-4-week washout period, then inulin for 2 weeks.

    Treatment: Inulin and Maltodextrin (Placebo)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women
Plain-language title
Inulin supplement for gut, heart and muscle health in perimenopausal women with overweightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07724522, who can take part
Record updated
11 August 2026