NCT05078203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

October 1, 2021

Last Update Submit

February 16, 2024

Conditions

Keywords

MyokineCognitionCTSBBDNFExercise

Outcome Measures

Primary Outcomes (6)

  • Circulating Cathepsin B (CTSB) Myokine

    Changes in peripheral myokine concentration

    3 hours

  • Attentional Inhibition Accuracy

    Behavioral performance measured as accuracy (%) during Flanker task

    3 hours

  • Attentional Inhibition Reaction Time

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

    3 hours

  • Attentional Resource Allocation

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

    3 hours

  • Attentional Processing Speed

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

    3 hours

  • Relational Memory

    Accuracy during a spatial reconstruction task

    3 hours

Secondary Outcomes (1)

  • Brain derived neurotrophic factor (BDNF)

    3 hours

Study Arms (2)

Exercise

EXPERIMENTAL

36 minutes of exercise

Behavioral: Exercise

Rest

PLACEBO COMPARATOR

36 minutes of rest

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

36 minutes of Exercise

ExerciseRest

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 14, 2021

Study Start

September 2, 2021

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations