Exercise-Induced Gut Permeability in Normal-weight Obesity

• Sponsor: Oklahoma State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05889767
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Normal-weight Obesity; Obesity	Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three study groups (n=10/ group): Normal weight and low body fat percent (BMI 18.5-24.9 kg/m2, body fat percent < 25% in males or < 35% in females), Normal-weight obesity (BMI 18.5-24.9 kg/m2, body fat percent > 25% in males or > 35% in female) Overt obesity and high body fat percent (BMI > 30 kg/m2, body fat percent > 25% in males or > 35% in females)Three study groups (n=10/ group):Normal weight and low body fat percent (BMI 18.5-24.9 kg/m2, body fat percent < 25% in males or < 35% in females), Normal-weight obesity (BMI 18.5-24.9 kg/m2, body fat percent > 25% in males or > 35% in female) Overt obesity and high body fat percent (BMI > 30 kg/m2, body fat percent > 25% in males or > 35% in females)
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise
• Actual Study Start Date: Jan 10, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)
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: 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)

Outcome Measures

Primary Outcome Measures

1. Serum concentrations of FABP2 following short, intense exercise [Approximately 8 months]

   The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.

2. Serum concentrations of LBP following short, intense exercise [Approximately 8 months]

   The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.

3. Serum concentrations of sCD14 following short, intense exercise [Approximately 8 months]

   The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.

4. Serum concentrations of FABP2 following sustained, moderate exercise [Approximately 8 months]

   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.

5. Serum concentrations of IL-6 following sustained, moderate exercise [Approximately 8 months]

   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.

Secondary Outcome Measures

1. VO2 Max [Approximately 8 months]

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

2. Respiratory exchange ratio (RER) during VO2 max test [Approximately 8 months]

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

3. Maximum workload during exercise sessions [Approximately 8 months]

   The investigators will compare workload dynamics in watts during the short, intense and moderate, sustained exercise session across study groups.

4. Heart rate dynamics during exercise sessions [Approximately 8 months]

   The investigators will compare heart rate dynamics during the short, intense and moderate, sustained exercise session across study groups.

Other Outcome Measures

1. Body fat percent assessment with dual-energy X-ray absorptiometry (DXA). [Approximately 8 months]

   The investigators will perform DXA scans on all participants to assess body fat percent.

2. Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA) [Approximately 8 months]

   The investigators will perform DXA scans on all participants to assess absolute body fat in kilograms.

3. Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA) [Approximately 8 months]

   The investigators will perform DXA scans on all participants to assess lean mass percent.

4. Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA) [Approximately 8 months]

   The investigators will perform DXA scans on all participants to assess absolute lean mass in kilograms.

5. Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA) [Approximately 8 months]

   The investigators will perform DXA scans on all participants to assess absolute visceral mass in grams.

6. Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer [Approximately 8 months]

   The investigators will perform a lipid panel on all participants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	208 Nancy Randolph Davis, Oklahoma State University	Stillwater	Oklahoma	United States	74078

Sponsors and Collaborators

• Oklahoma State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sam Emerson, Associate Professor of Nutritional Sciences, Oklahoma State University
• ClinicalTrials.gov Identifier: NCT05889767
• Other Study ID Numbers: IRB-22-28-STW
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Body Weight

Study Results

No Results Posted as of Jun 5, 2023