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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Recruiting

CT.gov ID

NCT05207488

Collaborator

(none)

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Dietary Supplement: Fructooligosaccharides (FOS) Behavioral: Exercise Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 20, 2022

Anticipated Study Completion Date :

Sep 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise + Prebiotic 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).	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.).
Placebo Comparator: Exercise + Placebo 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).	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. Other Names: Maltodextrin

Arm

Intervention/Treatment

Experimental: Exercise + Prebiotic

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).

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.).

Placebo Comparator: Exercise + Placebo

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).

Behavioral: Exercise

Dietary Supplement: Placebo

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

Other Names:

Maltodextrin

Outcome Measures

Primary Outcome Measures

Changes in gastrointestinal microbiota composition [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 [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.

Secondary Outcome Measures

Changes in fasting glucose [Baseline & 6-week mark]
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.
Changes in fasting insulin [Baseline & 6-week mark]
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.
Changes in body composition [Baseline & 6-week mark]
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.
Changes in body fat distribution [Baseline & 6-week mark]
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.
Changes in cognition [Baseline & 6-week mark]
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.

Other Outcome Measures

Changes in lipid profiles [Baseline & 6-week mark]
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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 and < 10 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)