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

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Fructooligosaccharides (FOS); Behavioral: Exercise; Dietary Supplement: Placebo

• Registration Number: NCT05207488
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study Start: 2021-10-01
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + Prebiotic	Fructooligosaccharides (FOS)	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).
Exercise + Prebiotic	Exercise	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).
Exercise + Placebo	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).
Exercise + Placebo	Exercise	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States