Exercise-Induced Gut Permeability in Normal-weight Obesity

Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Normal-weight Obesity
• Intervention / Treatment: Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryant H Keirns, MS; Phone Number: 3166891711; Email: bryant.keirns@okstate.edu
• Study Contact Backup: Name: Sam R Emerson, PhD; Phone Number: 405-744-2303; Email: sam.emerson@okstate.edu

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Recruiting
      • 208 Nancy Randolph Davis, Oklahoma State University
      • Contact: Bryant H Keirns, MS; Phone Number: 316-689-1711; Email: bryant.keirns@okstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal-weight obesity; 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).	Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max); All participants will complete two exercise sessions: VO2 max test on a cycle ergometer; Moderate exercise session (45 minutes at 65% measured VO2 max)
Active Comparator: Normal weight and low body fat percent; 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).	Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max); All participants will complete two exercise sessions: VO2 max test on a cycle ergometer; Moderate exercise session (45 minutes at 65% measured VO2 max)
Active Comparator: Overt obesity and high body fat percent; 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.	Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max); All participants will complete two exercise sessions: VO2 max test on a cycle ergometer; Moderate exercise session (45 minutes at 65% measured VO2 max)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 8 months
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.	Approximately 8 months
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.	Approximately 8 months
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.	Approximately 8 months
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.	Approximately 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 Max	The investigators will compare VO2 max after the short, intense exercise session across study groups.	Approximately 8 months
Respiratory exchange ratio (RER) during VO2 max test	The investigators will compare RER dynamics during the short, intense exercise session across study groups.	Approximately 8 months
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.	Approximately 8 months
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.	Approximately 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).	The investigators will perform DXA scans on all participants to assess body fat percent.	Approximately 8 months
Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)	The investigators will perform DXA scans on all participants to assess absolute body fat in kilograms.	Approximately 8 months
Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)	The investigators will perform DXA scans on all participants to assess lean mass percent.	Approximately 8 months
Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA)	The investigators will perform DXA scans on all participants to assess absolute lean mass in kilograms.	Approximately 8 months
Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA)	The investigators will perform DXA scans on all participants to assess absolute visceral mass in grams.	Approximately 8 months
Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer	The investigators will perform a lipid panel on all participants.	Approximately 8 months

Collaborators and Investigators

• Sponsor: Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Body Weight
• Other Study ID Numbers: IRB-22-28-STW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No