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

Overweight and Obesity Clinical Trial

— GAMEPLAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207488
• Other study ID #: 21730
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 20, 2023

Study information

• Verified date: November 2022
• Source: University of Illinois at Urbana-Champaign
• Contact: Mikaela Webb, BS, RD
• Phone: (217) 300-9577
• Email: mwebb24[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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

Behavioral:
• Exercise
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 Supplement:
• Placebo
Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in lipid profiles	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control.	Baseline & 6-week mark
Primary	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.	Baseline & 6-week mark
Primary	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.	Baseline & 6-week mark
Secondary	Changes in fasting glucose	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.	Baseline & 6-week mark
Secondary	Changes in fasting insulin	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.	Baseline & 6-week mark
Secondary	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.	Baseline & 6-week mark
Secondary	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.	Baseline & 6-week mark
Secondary	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.	Baseline & 6-week mark