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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05889767
Enrollment
30
Registered
2023-06-05
Start date
2023-01-10
Completion date
2023-08-01
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal-weight Obesity, Obesity

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.

Interventions

OTHERExercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)

All participants will complete two exercise sessions: 1. VO2 max test on a cycle ergometer 2. Moderate exercise session (45 minutes at 65% measured VO2 max)

Sponsors

Oklahoma State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Three study groups (n=10/ group): 1. Normal weight and low body fat percent (BMI 18.5-24.9 kg/m2, body fat percent \< 25% in males or \< 35% in females), 2. Normal-weight obesity (BMI 18.5-24.9 kg/m2, body fat percent \> 25% in males or \> 35% in female) 3. Overt obesity and high body fat percent (BMI \> 30 kg/m2, body fat percent \> 25% in males or \> 35% in females)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum concentrations of FABP2 following short, intense exerciseApproximately 8 monthsThe 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 IL-6 following sustained, moderate exerciseApproximately 8 monthsThe investigators will examine peak and absolute change in this inflammatory marker after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.
Serum concentrations of FABP2 following sustained, moderate exerciseApproximately 8 monthsThe 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 sCD14 following short, intense exerciseApproximately 8 monthsThe 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 exerciseApproximately 8 monthsThe investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.

Secondary

MeasureTime frameDescription
Respiratory exchange ratio (RER) during VO2 max testApproximately 8 monthsThe investigators will compare RER dynamics during the short, intense exercise session across study groups.
VO2 MaxApproximately 8 monthsThe investigators will compare VO2 max after the short, intense exercise session across study groups.
Maximum workload during exercise sessionsApproximately 8 monthsThe investigators will compare workload dynamics in watts during the short, intense and moderate, sustained exercise session across study groups.
Heart rate dynamics during exercise sessionsApproximately 8 monthsThe investigators will compare heart rate dynamics during the short, intense and moderate, sustained exercise session across study groups.

Other

MeasureTime frameDescription
Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)Approximately 8 monthsThe investigators will perform DXA scans on all participants to assess absolute body fat in kilograms.
Lipid panel with Abbott Piccolo Xpress Clinical Chemistry AnalyzerApproximately 8 monthsThe investigators will perform a lipid panel on all participants.
Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA)Approximately 8 monthsThe investigators will perform DXA scans on all participants to assess absolute lean mass in kilograms.
Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA)Approximately 8 monthsThe investigators will perform DXA scans on all participants to assess absolute visceral mass in grams.
Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).Approximately 8 monthsThe investigators will perform DXA scans on all participants to assess body fat percent.
Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)Approximately 8 monthsThe investigators will perform DXA scans on all participants to assess lean mass percent.

Countries

United States

Contacts

Primary ContactBryant H Keirns, MS
bryant.keirns@okstate.edu3166891711
Backup ContactSam R Emerson, PhD
sam.emerson@okstate.edu405-744-2303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026