Exercise-Induced Gut Permeability in Normal-weight Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889767
• Other study ID #: IRB-22-28-STW
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2023
• Source: Oklahoma State University
• Contact: Bryant H Keirns, MS
• Phone: 3166891711
• Email: bryant.keirns[@]okstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

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)

Locations

Country	Name	City	State
United States	208 Nancy Randolph Davis, Oklahoma State University	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer	The investigators will perform a lipid panel on all participants.	Approximately 8 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	VO2 Max	The investigators will compare VO2 max after the short, intense exercise session across study groups.	Approximately 8 months
Secondary	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
Secondary	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
Secondary	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