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Exercise + Prebiotic for Obesity (GAMEPLAN Trial)
N/A
Recruiting
Research Sponsored by University of Illinois at Urbana-Champaign
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline & 6-week mark
Summary
This trial is testing how taking a special type of fiber and doing regular exercise can improve gut health and overall well-being. It targets people who want to boost their gut health. The fiber feeds good bacteria in the gut, and exercise keeps the body healthy.
Eligible Conditions
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline & 6-week mark
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline & 6-week mark
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in gastrointestinal microbial-derived metabolite concentrations
Changes in gastrointestinal microbiota composition
Secondary study objectives
Changes in body composition
Changes in body fat distribution
Changes in cognition
+2 moreOther study objectives
Changes in lipid profiles
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise + PrebioticExperimental Treatment2 Interventions
The Exercise + Prebiotic intervention group will consume 10 g/d of fructo-oligosaccharides (FOS). Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).
Group II: Exercise + PlaceboPlacebo Group2 Interventions
The Exercise + Placebo group will consume 10 g/d of a placebo (maltodextrin) powder every day. Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820
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Who is running the clinical trial?
University of Illinois at Urbana-ChampaignLead Sponsor
197 Previous Clinical Trials
38,227 Total Patients Enrolled
26 Trials studying Obesity
2,585 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Exercise + Prebiotic
- Group 2: Exercise + Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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