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Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention

Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05207488
Acronym
GAMEPLAN
Enrollment
48
Registered
2022-01-26
Start date
2021-10-01
Completion date
2023-09-20
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition

Brief summary

This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.

Interventions

DIETARY_SUPPLEMENTFructooligosaccharides (FOS)

FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

BEHAVIORALExercise

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.).

DIETARY_SUPPLEMENTPlacebo

Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The study is a double-blind, placebo-controlled study.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in gastrointestinal microbial-derived metabolite concentrationsBaseline & 6-week markDetermine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.
Changes in gastrointestinal microbiota compositionBaseline & 6-week markDetermine 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.

Secondary

MeasureTime frameDescription
Changes in fasting insulinBaseline & 6-week markDetermine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.
Changes in body compositionBaseline & 6-week markDetermine 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.
Changes in cognitionBaseline & 6-week markDetermine 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.
Changes in body fat distributionBaseline & 6-week markDetermine 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.
Changes in fasting glucoseBaseline & 6-week markDetermine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.

Other

MeasureTime frameDescription
Changes in lipid profilesBaseline & 6-week markDetermine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control.

Countries

United States

Contacts

Primary ContactMikaela Webb, BS, RD
mwebb24@illinois.edu(217) 300-9577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026