Clinical trial NCT05889767: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Normal-weight Obesity
Obesity
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Serum concentrations of FABP2 following short, intense exercise
timeFrame: Approximately 8 months
measure: Serum concentrations of LBP following short, intense exercise
timeFrame: Approximately 8 months
measure: Serum concentrations of sCD14 following short, intense exercise
timeFrame: Approximately 8 months
measure: Serum concentrations of FABP2 following sustained, moderate exercise
timeFrame: Approximately 8 months
measure: Serum concentrations of IL-6 following sustained, moderate exercise
timeFrame: Approximately 8 months
Secondary outcomes:
measure: VO2 Max
timeFrame: Approximately 8 months
measure: Respiratory exchange ratio (RER) during VO2 max test
timeFrame: Approximately 8 months
measure: Maximum workload during exercise sessions
timeFrame: Approximately 8 months
measure: Heart rate dynamics during exercise sessions
timeFrame: Approximately 8 months
Other outcomes:
measure: Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).
timeFrame: Approximately 8 months
measure: Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)
timeFrame: Approximately 8 months
measure: Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)
timeFrame: Approximately 8 months
measure: Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA)
timeFrame: Approximately 8 months
measure: Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA)
timeFrame: Approximately 8 months
measure: Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer
timeFrame: Approximately 8 months
Locations:
city: Stillwater
country: United States
facility: 208 Nancy Randolph Davis, Oklahoma State University
state: Oklahoma
Study officials:
References: