Overweight and ObesityGAMEPLANNCT05207488
Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention
A study testing Fructooligosaccharides (FOS) and Exercise in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Fructooligosaccharides (FOS) and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-45 kg/m2
- Without physician diagnosed gastrointestinal or metabolic diseases
- Sedentary (< 30 minutes of moderate or high intensity exercise per week OR < 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
- Fully vaccinated against COVID-19
Who cannot join
- Fasting blood glucose >126 mg/dL
- Blood pressure >160/100 mm Hg
- Physician diagnosed metabolic or gastrointestinal diseases or constipation
- Heart conditions that may pose risk during exercise
- Taking oral hypoglycemic agents or insulin
- Pregnant, breastfeeding or postmenopausal
Show all 11Show fewer
- Smoke or consume > 2 alcoholic beverages/day, abuse drugs
- Have had > 5% weight change in the past month or > 10% change in the past year
- Have had any form of bariatric surgery or gallbladder removal
- Have taken antibiotics during the previous 3 months
- Unable to consume the experimental fiber
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Mikaela Webb, BS, RD
Jacob M Allen, PhD
About this study
Official title: Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)
This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.
- Conditions
- Overweight and Obesity
- Being tested
- Fructooligosaccharides (FOS), Exercise, Placebo
- Keywords
- Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructooligosaccharides (FOS)Dietary supplement
FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
ExerciseBehavioural
During the intervention period, all participants will perform 6 weeks of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk.).
PlaceboDietary supplement
Also called Maltodextrin
Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Prebiotic | Experimental | 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). Receives: Dietary Supplement: Fructooligosaccharides (FOS); Behavioral: Exercise |
| Exercise + Placebo | Placebo comparator | 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). Receives: Behavioral: Exercise; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastrointestinal microbiota composition
Determine the impact of daily consumption of prebiotic combined with regular exercise on the gastrointestinal microbiota compared to control by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Measured: Baseline & 6-week mark
Changes in gastrointestinal microbial-derived metabolite concentrations
Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.
Measured: Baseline & 6-week mark
Secondary outcomes (5)
Changes in fasting glucose
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.
Measured: Baseline & 6-week mark
Changes in fasting insulin
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.
Measured: Baseline & 6-week mark
Changes in body composition
Determine the impact of daily consumption of prebiotic combined with regular exercise on body composition compared to control. This includes percentage of fat mass and lean mass.
Measured: Baseline & 6-week mark
Changes in body fat distribution
Determine the impact of daily consumption of prebiotic combined with regular exercise on body fat distribution compared to control. This includes the weight of visceral fat and liver fat in kilograms.
Measured: Baseline & 6-week mark
Changes in cognition
Determine the impact of daily consumption of prebiotic combined with regular exercise on relational memory, hippocampal function, interference control, and selective attention compared to control. Outcomes will be assessed with computer tasks and participants will be equipped with an electrode cap.
Measured: Baseline & 6-week mark
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Oct 2021
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, controlled trial with a 6-week intervention period with two groups: 1) Exercise + Prebiotic and 2) Exercise + Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207488
- Sponsor's protocol ID
- 21730
- Acronym
- GAMEPLAN
- Status last verified
- Nov 2022
- First submitted
- 21 Sep 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)
- ClinicalTrials.gov ID
- NCT05207488
- Acronym / sponsor ID
- GAMEPLAN / 21730
- Conditions
- Overweight and Obesity
- Keywords
- Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, controlled trial with a 6-week intervention period with two groups: 1) Exercise + Prebiotic and 2) Exercise + Placebo.
| Arm | Type | Receives |
|---|---|---|
| Exercise + Prebiotic | Experimental | Dietary Supplement: Fructooligosaccharides (FOS), Behavioral: ExerciseThe 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). |
| Exercise + Placebo | Placebo comparator | Behavioral: Exercise, Dietary Supplement: PlaceboThe 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). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 18.5-45 kg/m2
- Without physician diagnosed gastrointestinal or metabolic diseases
- Sedentary (< 30 minutes of moderate or high intensity exercise per week OR < 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
- Fully vaccinated against COVID-19
Key exclusion criteria (11 listed)
- Fasting blood glucose >126 mg/dL
- Blood pressure >160/100 mm Hg
- Physician diagnosed metabolic or gastrointestinal diseases or constipation
- Heart conditions that may pose risk during exercise
- Taking oral hypoglycemic agents or insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructooligosaccharides (FOS)FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water. | Dietary supplement | Exercise + Prebiotic |
| ExerciseDuring the intervention period, all participants will perform 6 weeks of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk.). | Behavioural | Exercise + Placebo, Exercise + Prebiotic |
| PlaceboAlso: MaltodextrinMaltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water. | Dietary supplement | Exercise + Placebo |
Primary outcome
Changes in gastrointestinal microbiota composition
Time frame: Baseline & 6-week mark
Determine the impact of daily consumption of prebiotic combined with regular exercise on the gastrointestinal microbiota compared to control by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Changes in gastrointestinal microbial-derived metabolite concentrations
Time frame: Baseline & 6-week mark
Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.
5 secondary outcomes
Changes in fasting glucose
Time frame: Baseline & 6-week mark
Changes in fasting insulin
Time frame: Baseline & 6-week mark
Changes in body composition
Time frame: Baseline & 6-week mark
Changes in body fat distribution
Time frame: Baseline & 6-week mark
Changes in cognition
Time frame: Baseline & 6-week mark
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructooligosaccharides (FOS) and Exercise in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikaela Webb, BS, RD ((217) 300-9577, mwebb24@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gastrointestinal microbiota composition (time frame: Baseline & 6-week mark). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.