Exercise-Induced Gut Permeability in Normal-weight Obesity

NCT ID: NCT05889767

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Normal-weight Obesity Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 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).

Group Type EXPERIMENTAL

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

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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)

Interventions

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Exercise 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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Sam Emerson

Associate Professor of Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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208 Nancy Randolph Davis, Oklahoma State University

Stillwater, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bryant H Keirns, MS

Role: CONTACT

3166891711

Sam R Emerson, PhD

Role: CONTACT

405-744-2303

Facility Contacts

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Bryant H Keirns, MS

Role: primary

316-689-1711

Other Identifiers

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IRB-22-28-STW

Identifier Type: -

Identifier Source: org_study_id

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