Obesity & Overweight study: Inulin
Official title Prebiotic Inulin for Late-Reproductive Individuals
ClinicalTrials.gov ID: NCT07724522
What this study is testing
- What it's testing
- This study is testing whether inulin changes gut and vaginal microbes, heart health, and muscle health compared to a pretend treatment.
- Who it's for
- You may be able to join if you are a woman around menopause with a BMI over 25.
- What's involved
- You will take a small inulin or placebo capsule each day for 2 weeks, then switch after a short break. You will visit the clinic 8 times, call weekly, and wear a Fitbit to track activity.
- Time commitment
- The study lasts about 12 to 16 weeks, with 8 clinic visits and weekly phone calls.
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 55, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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;
See the full eligibility 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...
- 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...
- Fructose intolerance.
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.