No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 55
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
27 (estimated)
Sponsor
George Washington University · Other
Who this trial is looking for
This trial is looking for overweight women who are going through perimenopause. Participants will take a supplement for 2 weeks and attend regular appointments to share their health experiences.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index between 25 and 40.
I have an irregular menstrual cycle.
I have been weight stable for the last 3 months.
I spend at least 6 hours sitting each day.
I do not do more than 150 minutes of moderate to vigorous exercise each week.
You may not be able to join if
I have used antibiotics in the past 6 months.
I have been diagnosed with a chronic disease.
I take hormone replacement therapy or hormonal contraceptives.
I smoke.
I have given blood in the last 8-12 weeks.
I have had significant weight changes in the last 4 weeks.
I take dietary supplements that I haven’t stopped at least 4 weeks prior.
I have fructose intolerance.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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:
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 …
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.
Trial Locations
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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 month…
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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