ACE: Acute Cognition and Exercise

• Sponsor: University of Illinois at Urbana-Champaign (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05078203
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Exercise	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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)
• Primary Purpose: Prevention
• Official Title: Acute Exercise and Cognitive Function: Examining the Role of Weight Status and Exercise-Induced Myokines
• Actual Study Start Date: Sep 2, 2021
• Anticipated Primary Completion Date: Sep 2, 2022
• Anticipated Study Completion Date: Sep 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise 36 minutes of exercise	Behavioral: Exercise; 36 minutes of Exercise
Placebo Comparator: Rest 36 minutes of rest	Behavioral: Exercise; 36 minutes of Exercise

Outcome Measures

Primary Outcome Measures

1. Circulating Cathepsin B (CTSB) Myokine [3 hours]

   Changes in peripheral myokine concentration

2. Attentional Inhibition Accuracy [3 hours]

   Behavioral performance measured as accuracy (%) during Flanker task

3. Attentional Inhibition Reaction Time [3 hours]

   Behavioral performance measured as response time (ms) during Flanker task

4. Attentional Resource Allocation [3 hours]

   Changes in P3 event related potential amplitude (microvolts) using a computerized flanker task

5. Attentional Processing Speed [3 hours]

   Changes in P3 event related potential latency (ms) using a computerized flanker task

6. Relational Memory [3 hours]

   Accuracy during a spatial reconstruction task

Secondary Outcome Measures

1. Brain derived neurotrophic factor (BDNF) [3 hours]

   Changes in peripheral BDNF concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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)

Exclusion Criteria:

• <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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

Sponsors and Collaborators

• University of Illinois at Urbana-Champaign

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Illinois at Urbana-Champaign
• ClinicalTrials.gov Identifier: NCT05078203
• Other Study ID Numbers: ACE
• First Posted: Oct 14, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• 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
• Keywords provided by University of Illinois at Urbana-Champaign: Myokine; Cognition; CTSB; BDNF; Exercise

Study Results

No Results Posted as of Jun 1, 2022