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RecruitingNCT05889767Updated Jun 5, 2023

Exercise-Induced Gut Permeability in Normal-weight Obesity

An interventional study of Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max) in Normal-weight Obesity and Obesity, sponsored by Oklahoma State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Oklahoma State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Normal-weight Obesity
  • Obesity
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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)

  • 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)

  • 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)

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)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 8 months

  2. 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.

    Time frame: Approximately 8 months

  3. 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.

    Time frame: Approximately 8 months

  4. 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.

    Time frame: Approximately 8 months

  5. 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.

    Time frame: Approximately 8 months

Secondary outcomes

  1. VO2 Max

    The investigators will compare VO2 max after the short, intense exercise session across study groups.

    Time frame: Approximately 8 months

  2. Respiratory exchange ratio (RER) during VO2 max test

    The investigators will compare RER dynamics during the short, intense exercise session across study groups.

    Time frame: Approximately 8 months

  3. 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.

    Time frame: Approximately 8 months

  4. 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.

    Time frame: Approximately 8 months

Other outcomes

  1. 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.

    Time frame: Approximately 8 months

  2. 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.

    Time frame: Approximately 8 months

  3. 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.

    Time frame: Approximately 8 months

  4. 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.

    Time frame: Approximately 8 months

  5. 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.

    Time frame: Approximately 8 months

  6. Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer

    The investigators will perform a lipid panel on all participants.

    Time frame: Approximately 8 months

06

Study locations

1 of 1 sites recruiting
  • 208 Nancy Randolph Davis, Oklahoma State University
    Stillwater, Oklahoma 74078, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05889767
Lead sponsor
Oklahoma State University
Responsible party
Sam Emerson (Associate Professor of Nutritional Sciences, Oklahoma State University) — Principal investigator
First posted
Jun 5, 2023
Start date
Jan 10, 2023
Primary completion
Aug 1, 2023 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Jun 5, 2023

Study contacts

Bryant H Keirns, MS
Contact
bryant.keirns@okstate.edu
3166891711
Sam R Emerson, PhD
Contact
sam.emerson@okstate.edu
405-744-2303

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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