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

University of Illinois at Urbana-Champaign1 site in 1 country48 target enrollmentOctober 1, 2021

ConditionsOverweight and Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: University of Illinois at Urbana-Champaign
Enrollment: 48
Locations: 1
Primary Endpoint: Changes in gastrointestinal microbiota composition
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

September 20, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Illinois at Urbana-Champaign

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.