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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fructooligosaccharides (FOS)
Exercise
Placebo
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise + Prebiotic

Exercise + Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Changes in fasting glucose
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.
Changes in fasting insulin
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.
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.
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.
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.

Full Information

First Posted
September 21, 2021
Last Updated
November 9, 2022
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT05207488
Brief Title
Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention
Acronym
GAMEPLAN
Official Title
Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
The study is a double-blind, placebo-controlled study.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise + Prebiotic
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise + Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructooligosaccharides (FOS)
Intervention Description
FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
Primary Outcome Measure Information:
Title
Changes in gastrointestinal microbiota composition
Description
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.
Time Frame
Baseline & 6-week mark
Title
Changes in gastrointestinal microbial-derived metabolite concentrations
Description
Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.
Time Frame
Baseline & 6-week mark
Secondary Outcome Measure Information:
Title
Changes in fasting glucose
Description
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.
Time Frame
Baseline & 6-week mark
Title
Changes in fasting insulin
Description
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.
Time Frame
Baseline & 6-week mark
Title
Changes in body composition
Description
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.
Time Frame
Baseline & 6-week mark
Title
Changes in body fat distribution
Description
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.
Time Frame
Baseline & 6-week mark
Title
Changes in cognition
Description
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.
Time Frame
Baseline & 6-week mark
Other Pre-specified Outcome Measures:
Title
Changes in lipid profiles
Description
Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control.
Time Frame
Baseline & 6-week mark

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Unable to consume the experimental fiber
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikaela Webb, BS, RD
Phone
(217) 300-9577
Email
mwebb24@illinois.edu
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikaela Webb, BS, RD
First Name & Middle Initial & Last Name & Degree
Jacob M Allen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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