ObesityACENCT05078203
Acute Cognition and Exercise
A study testing Exercise in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 28 Apr 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between ages 18 and 35
- No prior diagnosis of neurological disorders (e.g., autism spectrum disorder)
- No prior diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- No physical disability that would preclude the participant from completing a VO2max test
- Corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
- Not pregnant
- BMI between 18.5 and 25.0 kg/m2, or BMI greater than 30.0 kg/m2
- Readiness for exercise (determined through PAR-Q)
Who cannot join
- <18 years and >35 years
- Diagnosis of neurological disorders (e.g., autism spectrum disorder)
- Diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- Physical disability that would preclude the participant from completing a VO2max test
- Lack of corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
- Pregnancy
- BMI less than 18.5 kg/m2 or BMI greater than 25.0 but less than 30.0 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Acute Exercise and Cognitive Function: Examining the Role of Weight Status and Exercise-Induced Myokines
The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Additionally, it is anticipated that the benefits of a single bout of exercise for cognitive control will be mediated by changes in exercise-induced myokines. These hypotheses will be tested by accomplishing three aims:
Aim 1: Elucidate the changes in cognitive control following an acute bout of exercise, relative to a sedentary condition, in persons with and without obesity.
Read more
Aim 2: To examine the effect of a single bout of exercise, relative to a sedentary condition, on myokines known to have neuroprotective effects i.e., BDNF and CTSB in both healthy weight and individuals with obesity.
Aim 3: To link changes in exercise-induced myokines (i.e., BDNF and CTSB) to changes in cognitive function, following a single bout of exercise.
Read the detailed description
18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order. A cognitive testing battery accompanied by an electroencephalogram (EEG) will be administered following each session. Blood samples will be collected prior to, during, and following each throughout each testing condition.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- Myokine, Cognition, CTSB, BDNF, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
36 minutes of Exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 36 minutes of exercise Receives: Behavioral: Exercise |
| Rest | Placebo comparator | 36 minutes of rest Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating Cathepsin B (CTSB) Myokine
Changes in peripheral myokine concentration
Measured: 3 hours
Attentional Inhibition Accuracy
Behavioral performance measured as accuracy (%) during Flanker task
Measured: 3 hours
Attentional Inhibition Reaction Time
Behavioral performance measured as response time (ms) during Flanker task
Measured: 3 hours
Attentional Resource Allocation
Changes in P3 event related potential amplitude (microvolts) using a computerized flanker task
Measured: 3 hours
Attentional Processing Speed
Changes in P3 event related potential latency (ms) using a computerized flanker task
Measured: 3 hours
Relational Memory
Accuracy during a spatial reconstruction task
Measured: 3 hours
Secondary outcomes (1)
Brain derived neurotrophic factor (BDNF)
Changes in peripheral BDNF concentration
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start2 Sep 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Model description
- 18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078203
- Sponsor's protocol ID
- ACE
- Acronym
- ACE
- Status last verified
- Feb 2024
- First submitted
- 1 Oct 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise and Cognitive Function: Examining the Role of Weight Status and Exercise-Induced Myokines
- ClinicalTrials.gov ID
- NCT05078203
- Acronym / sponsor ID
- ACE / ACE
- Conditions
- Obesity
- Keywords
- Myokine, Cognition, CTSB, BDNF, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 14 Oct 2021 (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.
The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Additionally, it is anticipated that the benefits of a single bout of exercise for cognitive control will be mediated by changes in exercise-induced myokines. These hypotheses will be tested by accomplishing three aims:
Aim 1: Elucidate the changes in cognitive control following an acute bout of exercise, relative to a sedentary condition, in persons with and without obesity.
Aim 2: To examine the effect of a single bout of exercise, relative to a sedentary condition, on myokines known to have neuroprotective effects i.e., BDNF and CTSB in both healthy weight and individuals with obesity.
Aim 3: To link changes in exercise-induced myokines (i.e., BDNF and CTSB) to changes in cognitive function, following a single bout of exercise.
Detailed description
18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order. A cognitive testing battery accompanied by an electroencephalogram (EEG) will be administered following each session. Blood samples will be collected prior to, during, and following each throughout each testing condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise36 minutes of exercise |
| Rest | Placebo comparator | Behavioral: Exercise36 minutes of rest |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between ages 18 and 35
- No prior diagnosis of neurological disorders (e.g., autism spectrum disorder)
- No prior diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- No physical disability that would preclude the participant from completing a VO2max test
- Corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
Key exclusion criteria (7 listed)
- <18 years and >35 years
- Diagnosis of neurological disorders (e.g., autism spectrum disorder)
- Diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- Physical disability that would preclude the participant from completing a VO2max test
- Lack of corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
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 |
|---|---|---|
| Exercise36 minutes of Exercise | Behavioural | Exercise, Rest |
Primary outcome
Circulating Cathepsin B (CTSB) Myokine
Time frame: 3 hours
Changes in peripheral myokine concentration
Attentional Inhibition Accuracy
Time frame: 3 hours
Behavioral performance measured as accuracy (%) during Flanker task
Attentional Inhibition Reaction Time
Time frame: 3 hours
Behavioral performance measured as response time (ms) during Flanker task
Attentional Resource Allocation
Time frame: 3 hours
Changes in P3 event related potential amplitude (microvolts) using a computerized flanker task
Attentional Processing Speed
Time frame: 3 hours
Changes in P3 event related potential latency (ms) using a computerized flanker task
Relational Memory
Time frame: 3 hours
Accuracy during a spatial reconstruction task
1 secondary outcome
Brain derived neurotrophic factor (BDNF)
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Obesity, run by University of Illinois at Urbana-Champaign 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 20 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating Cathepsin B (CTSB) Myokine (time frame: 3 hours). The study lists 6 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 20 Feb 2024.