Exercise-Induced Gut Permeability in Normal-weight Obesity

NCT05889767 | Unknown

• 1 other identifier: IRB-22-28-STW
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Normal-weight Obesity; Obesity

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• VO2 Max

  Approximately 8 months

• Respiratory exchange ratio (RER) during VO2 max test

  Approximately 8 months

• Maximum workload during exercise sessions

  Approximately 8 months

• Heart rate dynamics during exercise sessions

  Approximately 8 months

Other Outcomes (6)

• Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).

  Approximately 8 months

• Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)

  Approximately 8 months

• Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)

  Approximately 8 months

Study Arms (3)

Normal weight and low body fat percent

ACTIVE COMPARATOR

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)

Normal-weight obesity

EXPERIMENTAL

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)

Overt obesity and high body fat percent

ACTIVE COMPARATOR

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

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

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)

Normal weight and low body fat percent; Normal-weight obesity; Overt obesity and high body fat percent

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

208 Nancy Randolph Davis, Oklahoma State University

Stillwater, Oklahoma, 74078, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Bryant H Keirns, MS

CONTACT

3166891711; bryant.keirns@okstate.edu

Sam R Emerson, PhD

CONTACT

405-744-2303; sam.emerson@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Sciences

Model Details: 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)

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 5, 2023
• Study Start: January 10, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (1)