search
Back to results

Exercise-Induced Gut Permeability in Normal-weight Obesity

Primary Purpose

Normal-weight Obesity, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Normal-weight Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Control group: normal BMI, body fat percentage < 25% (male) or < 35% (female) Normal-weight obesity: normal BMI, body fat percentage > 25% (male) or > 35% (female) Overt obesity: BMI in obesity range, body fat percentage > 25% (male) or > 35% (female) Exclusion Criteria: Presence of pacemaker Pregnant Postmenopausal status History of chronically using of tobacco products, illicit drugs, anti-inflammatory drugs (e.g., NSAIDs), lipid lowering drugs Recent use of antibiotics (< 6 weeks) and NSAIDs (< 3 days) Established cardiometabolic disease (e.g., cardiovascular disease, type 2 diabetes) diseases inflammatory in nature (e.g., rheumatoid arthritis, inflammatory bowel disease), and/or diagnosed irritable bowel syndrome.

Sites / Locations

  • 208 Nancy Randolph Davis, Oklahoma State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Normal weight and low body fat percent

Normal-weight obesity

Overt obesity and high body fat percent

Arm Description

The low risk comparator group for this study will consist of individuals with normal BMI (18.5 - 24.9 kg/m2) and body fat percent < 25% (male) or < 35% (female).

Individuals with normal-weight obesity will be defined as having normal BMI (18.5 - 24.9 kg/m2), body fat percent > 25% (male) or > 35% (female).

Overt obesity (BMI > 30 kg/m2) with high body fat percent (> 25% [male] or > 35% [female]) will be used as a high-risk comparator group.

Outcomes

Primary Outcome Measures

Serum concentrations of FABP2 following short, intense exercise
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Serum concentrations of LBP following short, intense exercise
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Serum concentrations of sCD14 following short, intense exercise
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Serum concentrations of FABP2 following sustained, moderate exercise
The investigators will examine peak and absolute change in this indicator of gut permeability after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.
Serum concentrations of IL-6 following sustained, moderate exercise
The investigators will examine peak and absolute change in this inflammatory marker after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.

Secondary Outcome Measures

VO2 Max
The investigators will compare VO2 max after the short, intense exercise session across study groups.
Respiratory exchange ratio (RER) during VO2 max test
The investigators will compare RER dynamics during the short, intense exercise session across study groups.
Maximum workload during exercise sessions
The investigators will compare workload dynamics in watts during the short, intense and moderate, sustained exercise session across study groups.
Heart rate dynamics during exercise sessions
The investigators will compare heart rate dynamics during the short, intense and moderate, sustained exercise session across study groups.

Full Information

First Posted
May 4, 2023
Last Updated
June 2, 2023
Sponsor
Oklahoma State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05889767
Brief Title
Exercise-Induced Gut Permeability in Normal-weight Obesity
Official Title
Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University

4. Oversight

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

5. Study Description

Brief Summary
Exercise acutely increases gut permeability and inflammation, even in healthy populations. However, whether this response differs in groups at-risk for CVD that present with low-grade inflammation (e.g., normal-weight obesity) has yet to be examined. The investigators aim to measure serum indicators of gut permeability in those with normal-weight obesity pre- and post-short, intense exercise and sustained, moderate exercise
Detailed Description
The investigator's overall goal is to examine how indicators of gut permeability change in response to exercise in individuals with normal-weight obesity (i.e., normal body mass index [BMI] and high body fat percent) relative to those with a normal BMI and low body fat percent and those with a BMI in the obesity range and high body fat percent. The investigators will examine indicators of gut permeability (specified in primary outcomes) in response to a short, intense bout of exercise (i.e., VO2 max test on a cycle ergometer) and sustained, moderate bout of exercise (i.e., 45 minutes at 65% measured VO2 max on a cycle ergometer). Additionally, the investigators will measure basic anthropometrics, blood lipids and glucose, and body composition with DXA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal-weight Obesity, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three study groups (n=10/ group): Normal weight and low body fat percent (BMI 18.5-24.9 kg/m2, body fat percent < 25% in males or < 35% in females), Normal-weight obesity (BMI 18.5-24.9 kg/m2, body fat percent > 25% in males or > 35% in female) Overt obesity and high body fat percent (BMI > 30 kg/m2, body fat percent > 25% in males or > 35% in females)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal weight and low body fat percent
Arm Type
Active Comparator
Arm Description
The low risk comparator group for this study will consist of individuals with normal BMI (18.5 - 24.9 kg/m2) and body fat percent < 25% (male) or < 35% (female).
Arm Title
Normal-weight obesity
Arm Type
Experimental
Arm Description
Individuals with normal-weight obesity will be defined as having normal BMI (18.5 - 24.9 kg/m2), body fat percent > 25% (male) or > 35% (female).
Arm Title
Overt obesity and high body fat percent
Arm Type
Active Comparator
Arm Description
Overt obesity (BMI > 30 kg/m2) with high body fat percent (> 25% [male] or > 35% [female]) will be used as a high-risk comparator group.
Intervention Type
Other
Intervention Name(s)
Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)
Intervention Description
All participants will complete two exercise sessions: VO2 max test on a cycle ergometer Moderate exercise session (45 minutes at 65% measured VO2 max)
Primary Outcome Measure Information:
Title
Serum concentrations of FABP2 following short, intense exercise
Description
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Time Frame
Approximately 8 months
Title
Serum concentrations of LBP following short, intense exercise
Description
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Time Frame
Approximately 8 months
Title
Serum concentrations of sCD14 following short, intense exercise
Description
The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.
Time Frame
Approximately 8 months
Title
Serum concentrations of FABP2 following sustained, moderate exercise
Description
The investigators will examine peak and absolute change in this indicator of gut permeability after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.
Time Frame
Approximately 8 months
Title
Serum concentrations of IL-6 following sustained, moderate exercise
Description
The investigators will examine peak and absolute change in this inflammatory marker after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.
Time Frame
Approximately 8 months
Secondary Outcome Measure Information:
Title
VO2 Max
Description
The investigators will compare VO2 max after the short, intense exercise session across study groups.
Time Frame
Approximately 8 months
Title
Respiratory exchange ratio (RER) during VO2 max test
Description
The investigators will compare RER dynamics during the short, intense exercise session across study groups.
Time Frame
Approximately 8 months
Title
Maximum workload during exercise sessions
Description
The investigators will compare workload dynamics in watts during the short, intense and moderate, sustained exercise session across study groups.
Time Frame
Approximately 8 months
Title
Heart rate dynamics during exercise sessions
Description
The investigators will compare heart rate dynamics during the short, intense and moderate, sustained exercise session across study groups.
Time Frame
Approximately 8 months
Other Pre-specified Outcome Measures:
Title
Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).
Description
The investigators will perform DXA scans on all participants to assess body fat percent.
Time Frame
Approximately 8 months
Title
Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)
Description
The investigators will perform DXA scans on all participants to assess absolute body fat in kilograms.
Time Frame
Approximately 8 months
Title
Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)
Description
The investigators will perform DXA scans on all participants to assess lean mass percent.
Time Frame
Approximately 8 months
Title
Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA)
Description
The investigators will perform DXA scans on all participants to assess absolute lean mass in kilograms.
Time Frame
Approximately 8 months
Title
Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA)
Description
The investigators will perform DXA scans on all participants to assess absolute visceral mass in grams.
Time Frame
Approximately 8 months
Title
Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer
Description
The investigators will perform a lipid panel on all participants.
Time Frame
Approximately 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Control group: normal BMI, body fat percentage < 25% (male) or < 35% (female) Normal-weight obesity: normal BMI, body fat percentage > 25% (male) or > 35% (female) Overt obesity: BMI in obesity range, body fat percentage > 25% (male) or > 35% (female) Exclusion Criteria: Presence of pacemaker Pregnant Postmenopausal status History of chronically using of tobacco products, illicit drugs, anti-inflammatory drugs (e.g., NSAIDs), lipid lowering drugs Recent use of antibiotics (< 6 weeks) and NSAIDs (< 3 days) Established cardiometabolic disease (e.g., cardiovascular disease, type 2 diabetes) diseases inflammatory in nature (e.g., rheumatoid arthritis, inflammatory bowel disease), and/or diagnosed irritable bowel syndrome.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bryant H Keirns, MS
Phone
3166891711
Email
bryant.keirns@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sam R Emerson, PhD
Phone
405-744-2303
Email
sam.emerson@okstate.edu
Facility Information:
Facility Name
208 Nancy Randolph Davis, Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryant H Keirns, MS
Phone
316-689-1711
Email
bryant.keirns@okstate.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exercise-Induced Gut Permeability in Normal-weight Obesity

We'll reach out to this number within 24 hrs