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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
BMI 18.5-45 kg/m2
Without physician diagnosed gastrointestinal or metabolic diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline & 6-week mark
Awards & highlights

GAMEPLAN Trial Summary

This triallooks at how prebiotics, fibers, and exercise affect gut health and wellbeing.

Eligible Conditions
  • Overweight and Obesity

GAMEPLAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your body mass index (BMI) falls within the range of 18.5 to 45 kg/m2.
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You do not have any gastrointestinal or metabolic diseases diagnosed by a doctor.
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You do not engage in physical activity for at least 30 minutes each week or have a low score on a physical activity questionnaire.
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You have received all recommended doses of the COVID-19 vaccine.

GAMEPLAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline & 6-week mark
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline & 6-week mark for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in gastrointestinal microbial-derived metabolite concentrations
Changes in gastrointestinal microbiota composition
Secondary outcome measures
Changes in body composition
Changes in body fat distribution
Changes in cognition
+2 more
Other outcome measures
Changes in lipid profiles

GAMEPLAN 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
~760

Find a Location

Who is running the clinical trial?

University of Illinois at Urbana-ChampaignLead Sponsor
188 Previous Clinical Trials
37,277 Total Patients Enrolled
23 Trials studying Obesity
2,490 Patients Enrolled for Obesity

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05207488 — N/A
Obesity Research Study Groups: Exercise + Prebiotic, Exercise + Placebo
Obesity Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05207488 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05207488 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of enrollment for this research?

"Affirmative. Clinicaltrials.gov provides evidence that this medical venture, which was initially posted on October 1st 2021, remains open for recruitment. A total of 48 participants are wanted from one location."

Answered by AI

Are the enrollment criteria for this investigation still open?

"According to information posted on clinicaltrials.gov, this trial is currently enrolling patients with the initial posting date being October 1st 2021 and the most recent update occuring November 9th 2022."

Answered by AI

Is this research effort extending its reach to geriatric patients?

"The age range for individuals eligible to join this trial is between 20 and 45 years old. Conversely, there are 54 trials available to those younger than 18 and 206 studies suited for adults 65 or older."

Answered by AI

What are the main goals to be achieved from this investigation?

"The primary metric of this study, measured from the baseline and 6-week mark, is transformation in gastrointestinal microbial-derived metabolite concentrations. Secondary objectives consist of monitoring changes to fasting insulin levels, body composition (percentage fat mass vs lean mass), and body fat distribution (kilograms of visceral & liver fat)."

Answered by AI

Could I participate in this experiment if my requirements are met?

"To participate in the trial, patients must be within the age bracket of 20 to 45 and demonstrate a BMI rating that qualifies them as obese. The research team is seeking 48 individuals for this study."

Answered by AI
~14 spots leftby Mar 2025