Normal-weight ObesityNCT05889767
Exercise-Induced Gut Permeability in Normal-weight Obesity
A study testing Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max) in people with Normal-weight Obesity and Obesity, run by Oklahoma State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal-weight Obesity, Obesity
- What is being tested?
- Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
208 Nancy Randolph Davis, Oklahoma State University
Stillwater, Oklahoma, 74078
Bryant H Keirns, MS, 316-689-1711, bryant.keirns@okstate.edu
About this study
Official title: Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise
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
Read the 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.
- Conditions
- Normal-weight Obesity, Obesity
- Being tested
- Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)Other
All participants will complete two exercise sessions:
- VO2 max test on a cycle ergometer
- Moderate exercise session (45 minutes at 65% measured VO2 max)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 8 months
Secondary outcomes (4)
VO2 Max
The investigators will compare VO2 max after the short, intense exercise session across study groups.
Measured: Approximately 8 months
Respiratory exchange ratio (RER) during VO2 max test
The investigators will compare RER dynamics during the short, intense exercise session across study groups.
Measured: Approximately 8 months
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.
Measured: Approximately 8 months
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.
Measured: Approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start10 Jan 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal-weight ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Emerson, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889767
- Sponsor's protocol ID
- IRB-22-28-STW
- Status last verified
- Jun 2023
- First submitted
- 4 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise
- ClinicalTrials.gov ID
- NCT05889767
- Acronym / sponsor ID
- IRB-22-28-STW
- Conditions
- Normal-weight Obesity, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Normal weight and low body fat percent | Active comparator | Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)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). |
| Normal-weight obesity | Experimental | Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)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). |
| Overt obesity and high body fat percent | Active comparator | Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Normal weight and low body fat percent, Normal-weight obesity, Overt obesity and high body fat percent |
Primary outcome
Serum concentrations of FABP2 following short, intense exercise
Time frame: 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.
Serum concentrations of LBP following short, intense exercise
Time frame: 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.
Serum concentrations of sCD14 following short, intense exercise
Time frame: 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.
Serum concentrations of FABP2 following sustained, moderate exercise
Time frame: 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.
Serum concentrations of IL-6 following sustained, moderate exercise
Time frame: 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.
4 secondary outcomes
VO2 Max
Time frame: Approximately 8 months
Respiratory exchange ratio (RER) during VO2 max test
Time frame: Approximately 8 months
Maximum workload during exercise sessions
Time frame: Approximately 8 months
Heart rate dynamics during exercise sessions
Time frame: Approximately 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max) in people with Normal-weight Obesity and Obesity, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bryant H Keirns, MS (3166891711, bryant.keirns@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of FABP2 following short, intense exercise (time frame: Approximately 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.