An interventional study of Aerobic Exercise in Weight Management, Obesity and Exercise, sponsored by George Washington University. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by George Washington University · Not applicable, Interventional, and Prevention
Among 11 studies in Obesity by George Washington University — 3 open to participants now, 4 under way, none of them phase 3. Obesity · George Washington University.
Among the 11 studies in Obesity by George Washington University, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2024, is one of 10 with no phase, and was the 8th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →3 of the 11 studies in Obesity by George Washington University are open now, in 1 country. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 21 Years to 40 Years · female · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2024.
Median enrollment 27 across the 11 interventional studies. Of the 7 that completed or were terminated, 0 (0%) have results posted.
George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
1 of the studies in Obesity by George Washington University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06691100George Washington UniversityHow a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types | 2027-06-01 |
Among the 11 studies in Obesity by George Washington University, from their registry updates:
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:
Participants who are eligible after completing the online questionnaire will be invited to three in-person visits:
VISIT A (baseline visit)
At VISIT B (exercise test day), after 7 to 12 days after VISIT A, the following procedures will happen:
At VISIT C (24 hours post-exercise), after 24 hours from VISIT B, the following procedures will happen:
Potential Risks There are minimal risks associated with this protocol. This study involves a fitness test, two strength tests, and an acute 30-minute exercise bout. The primary risks associated with this protocol are those related to sample collection, including blood and other biological specimen collection procedures, which are typical procedures in the METLAB. Potential discomforts associated with a blood draw are bruising and possible infections. Risks associated with collecting stool samples are no more than those experienced during regular bowel movements. All participants will undergo a cardiovascular fitness test with potential risks like dizziness, dehydration, muscle soreness, or cardiovascular events. Additionally, those participants in the exercise group will be at risk for minimal risk derived from the exercise training, like muscle sprain. The risk of data confidentiality and security loss will be minimized by reducing exposure to risks. These risks will be presented to volunteers before enrollment during the consent process. For volunteers interested in participating in the study, written, signed consent will be obtained.
Steps taken to minimize risks and to protect subjects' welfare To minimize risks and protect the subjects' welfare, IRB approval and written consent from participants for voluntary participation will be obtained. All participants will be provided with a de-identified study ID for confidentiality. All safety and risk assessments are in place at the laboratory to ensure the participants' risks for participating in an exercise trial. Ongoing monitoring and reporting of any adverse effects will be maintained
Blood collection: The blood collection will take place at the GW Metabolic and Exercise Testing Laboratory (METLAB) and will be performed using aseptic techniques by a trained phlebotomist to minimize any ill effects from all blood draws. Participants will be monitored for potential side effects of blood draws, including dizziness, lightheadedness, and nausea.
Stool Collection: Participants will be provided with a discrete at-home stool collection kit to minimize the potential discomfort that might be caused by the collection of stool samples. Briefly, a pair of gloves, a collection container, packaging, and storage material (e.g., 24-hour ice pack) will be provided.
Cardiovascular fitness test (VO2peak): Performing a cardiovascular fitness test typically involves physical exertion. This is a test performed on a regular basis at METLAB. A trained and qualified research staff member will guide the test and instruct the participant along the way. All minimal risks will be reduced by performing the VO2peak test according to the targeted population (adults with obesity); vital signs, including heart rate and blood pressure, will be monitored, and clear instructions will be provided to ensure proper hydration before the test. Participants will be instructed to warm up and cool down, followed by a post-test evaluation to evaluate any symptoms experienced.
Exercise Training Prescription and Supervised Exercise Bout: Risks of the exercise bout will be minimized by ensuring that all participants meet specific inclusion/exclusion criteria. If fatigue or shortness of breath occurs during exercise sessions, rest will be recommended to allow completion of the prescribed exercise. For muscle soreness, light stretching and hot/cold therapy will be recommended to reduce discomfort, and if needed, over-the-counter pain relievers (e.g., aspirin, acetaminophen, ibuprofen) will be advised unless contraindicated. Some soreness is anticipated during the first few days of the intervention, but due to the low-impact, moderately intense nature of the exercises (e.g., cycling), symptoms are expected to be minor and transient. Although minor to moderate orthopedic injuries may occur, severe injuries are not anticipated given the intensity of the prescribed exercise. A trained research assistant will oversee the exercise bout to ensure the correct intensity and monitor for adverse events. During testing, a CPR/AED-certified research team member will always be present, ensuring participants are not left unaccompanied during exercise testing and cool-down. The GW METLAB is equipped with an AED, and prior to each exercise session, participants will be asked about any health changes that may affect their ability to continue in the study.
Data Confidentiality: Confidentiality of all records is strictly maintained by established procedures. All participants found eligible will be randomly assigned a three-digit participant identification number. All data collected, including blood samples, will be labeled with participant ID numbers and never identifying information. All identifiable participant information, including signed consent forms, will be kept locked in a cabinet and secured in the private office of Dr. Ortega-Santos. PI will store the master key file at GW encrypted servers, to which she will have access. Study personnel will have access only under the supervision and prior approval of PI. All de-identified study data will be collected and managed using REDCap (Research Electronic Data Capture). REDCap is a secure web application designed to support data capture for research studies, providing user-friendly web-based case report forms, real-time data entry validation (e.g., for data types and range checks), audit trails, and a de-identified data export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was developed by a multi-institutional consortium, which includes GWU, and was initiated at Vanderbilt University. All the de-identified data from sequences.
Reporting of Adverse Events. The PI and study staff are familiar with the policies and procedures of the GWU IRB. During data collection, any reports by participants of minor discomfort or any observations of a potential adverse event, whether obviously directly related to the protocol or not, will be noted and reported to the IRB for a determination regarding whether to submit a formal report. A more serious adverse event will be reported immediately, and precautionary measures will be implemented at that time. The PI will then be responsible for reporting any adverse events to the IRB. The PI and the research assistant will then work to ensure other monitoring and reporting requirements are met as appropriate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).
Behavioral: Aerobic Exercise
30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).
Gut Microbiome Composition
Shotgun metagenomics will be used to examine the abundance of specific SCFA-producing bacteria in the stool (e.g., Ruminococcus)
Time frame: Before the exercise intervention and immediately after the intervention
Gut Microbiome Function
Shotgun metagenomics will be used to examine the BGCs (i.e., the genes within the microbial genome that dictate gut microbial functionality) to investigate functional downstream metabolic activity.
Time frame: Before the exercise intervention and immediately after the intervention
Plasma Metabolome
Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in plasma before and after the exercise intervention
Time frame: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention
Stool Metabolome
Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in stool before and after the exercise intervention
Time frame: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention
Plan to share: No — We will not be sharing individual participant data (IPD) for this study. Protecting participant privacy is a priority; even de-identified data carries a risk of re-identification, particularly in a smaller sample.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2027, 31 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 31 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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