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Prebiotic Inulin for Late-Reproductive Individuals

A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will also complete questionnaires related to dietary intake, physical activity, sleep, menopausal symptoms, and quality of life, while wearing a Fitbit device to objectively monitor physical activity and sleep throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests inulin, a prebiotic supplement, in women with overweight or obesity who are nearing menopause. It compares inulin with a look-alike supplement without inulin to see how they affect gut and vaginal microbes that process estrogen, heart and blood vessel health, and muscle health. Participants take each supplement for 2 weeks, with a break between them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, of 25 to 40.
  • Have irregular periods: cycles shorter than 21 days or longer than 35 days, or cycle lengths that vary by more than 7 days; and/or have skipped at least 2 periods with at least 60 days without a period.
  • May have hot flashes or night sweats, but these are not required.
  • Have had a steady weight over the past 3 months, with changes within 5% of usual body weight.
  • Spend at least 6 hours sitting.
  • Do less than 150 minutes of planned moderate to hard exercise each week.

Who can't join

  • Recent use of antibiotics by mouth or in the vagina. The listed 6-month timing is unclear; ask the study team.
  • Have a long-term disease, such as bowel disease, type 2 diabetes, or cancer. There is an exception for stable treatment of conditions such as high blood pressure or high cholesterol if medicines have not changed for at least 2 years.
  • Are prescribed hormone replacement therapy, hormonal birth control, probiotics, GLP-1 medicines, or weight-loss medicines.
  • Smoke.
  • Donated blood within the past 8–12 weeks, or had a weight change of 5% or more in the past 4 weeks.
  • Use dietary supplements, unless stopped 4 weeks before the study.
  • Had medicine changes within the past 6 months, started new prescriptions, or use medicines known to affect how the body uses energy, blood vessels, the vagina, hormones, or digestion.
  • Have fructose intolerance, meaning trouble digesting fructose, a type of sugar.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

DC