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Behavioral Intervention
Aerobic Exercise for Gut Health (FITGut-W Trial)
N/A
Recruiting
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI 19 to 24.99 kg/m2 or BMI 30-40 kg/m2
Biological sex: female
Must not have
Biological sex: male
Currently pregnant, < 2 years postpartum, lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before the exercise intervention and immediately after the intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the differences in the gut microbiome and metabolites in adult women with different fitness levels and BMIs. They want to see how a 30-minute aerobic exercise session affects the
Who is the study for?
This trial is for premenopausal women with varying fitness levels and body sizes, specifically including those who are obese. Participants should be interested in how a single session of aerobic exercise can affect their gut bacteria.
What is being tested?
The study is testing the impact of a 30-minute aerobic workout at moderate intensity (60-70% heart rate reserve) on the gut microbiome's function and metabolites in blood and stool, focusing on short-chain fatty acid production.
What are the potential side effects?
Since this trial involves moderate exercise, potential side effects may include muscle soreness, fatigue, or mild discomfort during or after the workout. No severe side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is either between 19-24.99 or 30-40.
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I am female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am male.
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I am currently pregnant, less than 2 years postpartum, or breastfeeding.
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I am currently taking herbal, fiber, or prebiotic supplements.
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I have been diagnosed with a disease related to the stomach, hormones, digestion, cancer, or heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gut Microbiome Composition
Gut Microbiome Function
Plasma Metabolome
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1350
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
255 Previous Clinical Trials
466,600 Total Patients Enrolled
4 Trials studying Obesity
912 Patients Enrolled for Obesity