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Impact of Acute Exercise Intensity and Pattern on Cytokine Function (AEX)

Primary Purpose

Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Moderate intensity continuous exercise
High intensity continuous exercise
High intensity interval exercise
Resting (no exercise) control
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Exercise, Cytokines, Leukocytes, Interleukin-10, Interleukin-6

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-35 years of age
  • Body mass index between 18.5-30 kg/m^2
  • Free of cardiometabolic and autoimmune/inflammatory disease

Exclusion Criteria:

  • Competitive endurance athlete
  • Cigarette smoker
  • Currently taking immunomodulatory/anti-inflammatory medications
  • Currently pregnant

Sites / Locations

  • UBC OkanaganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Resting (no exercise) control

Moderate intensity continuous exercise (MICE)

High intensity continuous exercise (HICE)

High intensity interval exercise (HIIT)

Arm Description

Resting (no exercise) control condition

Experimental session involving an acute bout of moderate intensity continuous exercise (MICE; continous cycling expending 350 kcal at 70% of lactate threshold)

Experimental session involving an acute bout of high intensity continuous exercise (HICE; continuous cycling expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)

Experimental session involving an acute bout of high intensity interval exercise (HIIT; cycling intervals expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)

Outcomes

Primary Outcome Measures

IL-10 mediated STAT3 phosphorylation
Ex vivo leukocyte STAT3 phosphorylation in response to IL-10 treatment

Secondary Outcome Measures

IL-10 mediated TNF-alpha inhibition
Ex vivo inhibition of TNF-alpha production in response to IL-10 treatment
IL-6 mediated STAT3 phosphorylation
Ex vivo leukocyte STAT3 phosphorylation in response to IL-6 treatment
IL-6 mediated TNF-alpha inhibition
Ex vivo inhibition of TNF-alpha production in response to IL-6 treatment
Plasma IL-10
Concentration of IL-10 in plasma samples
Plasma IL-6
Concentration of IL-6 in plasma samples
Plasma TNF-alpha
Concentration of TNF-alpha in plasma samples
Hematology panel
Complete blood count
Extracellular vesicles
Concentration of extracellular vesicles in plasma

Full Information

First Posted
October 6, 2022
Last Updated
May 12, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05574413
Brief Title
Impact of Acute Exercise Intensity and Pattern on Cytokine Function
Acronym
AEX
Official Title
Impact of Acute Exercise Intensity and Pattern on Cytokine Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The immune system helps prevent illness, fights off infections, and repairs damaged tissues following an injury. However, when immune cells remain active for prolonged periods of time - a state known as "chronic inflammation" - they can contribute to the development and progression of chronic diseases like heart disease and diabetes. Exercise can reduce the risk of developing many of these diseases and at least part of the health benefits of exercise are due to the ability of exercise to reduce "chronic inflammation". The inflammation-lowering effects of exercise are typically captured by measuring hormone-like molecules released from immune cells called "cytokines" in the blood. In addition to changes in circulating cytokine levels, exercise may also alter how immune cells respond to these cytokines. How exercise intensity (i.e., how hard you are working during exercise) and pattern (i.e., exercising as a long continuous bout or in short intervals) impact the ability of immune cells to respond to cytokines is not well understood. A better understanding of how exercise intensity and pattern of exercise for reducing chronic inflammation may help determine the best types of exercises for improving health and preventing chronic diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Exercise, Cytokines, Leukocytes, Interleukin-10, Interleukin-6

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Repeated measures randomized counterbalanced crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resting (no exercise) control
Arm Type
Placebo Comparator
Arm Description
Resting (no exercise) control condition
Arm Title
Moderate intensity continuous exercise (MICE)
Arm Type
Experimental
Arm Description
Experimental session involving an acute bout of moderate intensity continuous exercise (MICE; continous cycling expending 350 kcal at 70% of lactate threshold)
Arm Title
High intensity continuous exercise (HICE)
Arm Type
Experimental
Arm Description
Experimental session involving an acute bout of high intensity continuous exercise (HICE; continuous cycling expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)
Arm Title
High intensity interval exercise (HIIT)
Arm Type
Experimental
Arm Description
Experimental session involving an acute bout of high intensity interval exercise (HIIT; cycling intervals expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)
Intervention Type
Other
Intervention Name(s)
Moderate intensity continuous exercise
Other Intervention Name(s)
MICE
Intervention Description
Participants will perform an acute bout of continuous cycling at 70% of the power output at lactate threshold until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Intervention Type
Other
Intervention Name(s)
High intensity continuous exercise
Other Intervention Name(s)
HICE
Intervention Description
Participants will perform an acute bout of continuous cycling at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Intervention Type
Other
Intervention Name(s)
High intensity interval exercise
Other Intervention Name(s)
HIIE
Intervention Description
Participants will perform an acute bout of interval cycling at at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Intervention Type
Other
Intervention Name(s)
Resting (no exercise) control
Other Intervention Name(s)
CTL
Intervention Description
Participants will remain in a rested state (i.e., no exercise) for the entire session. Blood samples will be obtained at the same time-points as the exercise sessions.
Primary Outcome Measure Information:
Title
IL-10 mediated STAT3 phosphorylation
Description
Ex vivo leukocyte STAT3 phosphorylation in response to IL-10 treatment
Time Frame
Change from pre-exercise to immediately and 90-min post-exercise
Secondary Outcome Measure Information:
Title
IL-10 mediated TNF-alpha inhibition
Description
Ex vivo inhibition of TNF-alpha production in response to IL-10 treatment
Time Frame
Change from pre-exercise to immediately and 90-min post-exercise
Title
IL-6 mediated STAT3 phosphorylation
Description
Ex vivo leukocyte STAT3 phosphorylation in response to IL-6 treatment
Time Frame
Change from pre-exercise to immediately and 90-min post-exercise
Title
IL-6 mediated TNF-alpha inhibition
Description
Ex vivo inhibition of TNF-alpha production in response to IL-6 treatment
Time Frame
Change from pre-exercise to immediately and 90-min post-exercise
Title
Plasma IL-10
Description
Concentration of IL-10 in plasma samples
Time Frame
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Title
Plasma IL-6
Description
Concentration of IL-6 in plasma samples
Time Frame
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Title
Plasma TNF-alpha
Description
Concentration of TNF-alpha in plasma samples
Time Frame
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Title
Hematology panel
Description
Complete blood count
Time Frame
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Title
Extracellular vesicles
Description
Concentration of extracellular vesicles in plasma
Time Frame
Change from pre-exercise to immediately, 30-, and 90-min post-exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-35 years of age Body mass index between 18.5-30 kg/m^2 Free of cardiometabolic and autoimmune/inflammatory disease Exclusion Criteria: Competitive endurance athlete Cigarette smoker Currently taking immunomodulatory/anti-inflammatory medications Currently pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashim Islam, PhD
Phone
250.807.9876
Email
hashim.islam@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PhD
Organizational Affiliation
UBC Okanagan
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashim Islam, PhD
Phone
250.807.9876
Email
hashim.islam@ubc.ca
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PhD

12. IPD Sharing Statement

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Impact of Acute Exercise Intensity and Pattern on Cytokine Function

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