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

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

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Fructooligosaccharides (FOS)
* Behavioral: Exercise
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise + Prebiotic<br>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)<br>* FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.<br>Behavioral: Exercise<br>* 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.).<br>|
| Placebo Comparator: Exercise + Placebo<br>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<br>* 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.).<br>Dietary Supplement: Placebo<br>* Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition