NCT06691100 · George Washington University
How a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types
(FITGut-W)
What this study is about
This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity).
View original scientific description
This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows: * Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity. * Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Biological sex: female
- BMI 19 to 24.99 kg/m2 or BMI 30-40 kg/m2
- Exercisers: Exercise at least 4 times per week for 60 minutes (a total of 240 minutes per week) on a programmed exercise training either on endurance sports (e.g., running, cycling, triathlon), strength (e.g., powerlifting), or team sports (e.g., rugby, football, soccer)
- Non-Exercisers: Sedentary individuals who have not reached the PA guidelines (150 minutes of moderate-intensity physical activity a week, 75 minutes of vigorous-intensity physical activity, or an equivalent combination of moderate and vigorous-intensity physical activity).
Exclusion criteria
- Biological sex: male
- BMI \< 19 kg/m2 or \> 40 kg/m2
- Currently pregnant, \< 2 years postpartum, lactating
- Currently taking any herbal, fiber, or prebiotic supplement
- Current or 1-month before the study, taking oral or vaginal antibiotics
- Diagnosed with any gastrointestinal, endocrine, digestive, cancer, or cardiovascular disease.
Where
- Washington D.C., District of Columbia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations