NCT03975777

Brief Summary

This study examines the impact of exercise intensity on the 12-hour time-course of mitochondrial biogenic gene and protein expression in human skeletal muscle. Briefly, participants will perform two experimental sessions involving an acute bout of work-matched low- or high-intensity interval cycling exercise in a randomized crossover fashion, two weeks apart. Skeletal muscle biopsies will be obtained from the vastus lateralis (3 from each leg) before and 1, 3, 6, 9, and 12 hours post-exercise. Changes in the expression of various transcription factors and mitochondrial proteins will be examined at the mRNA and protein level to determine the time-course of changes in these factors differs between exercise protocols of different intensities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

May 29, 2019

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in peroxisome proliferator activated receptor (PPAR) gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression

    PGC-1α gene expression (indirect indicator of PGC-1α activity). Transcriptional co-activator involved in the control of mitochondrial biogenesis.

    before exercise to 1, 3, 6, 9, and 12 hours post-exercise

Secondary Outcomes (21)

  • Change in PGC-1α protein content

    before exercise to 1, 3, 6, 9, and 12 hours post-exercise

  • Change in nuclear factor-erythroid 2 like 2 (Nrf2) mRNA expression

    before exercise to 1, 3, 6, 9, and 12 hours post-exercise

  • Change in Nrf2 protein content

    before exercise to 1, 3, 6, 9, and 12 hours post-exercise

  • Change in PPAR-beta mRNA expression

    before exercise to 1, 3, 6, 9, and 12 hours post-exercise

  • Change in estrogen related receptor (ERR)-gamma mRNA expression

    before exercise and 1, 3, 6, 9, and 12 hours post-exercise

  • +16 more secondary outcomes

Study Arms (2)

low-intensity exercise - high-intensity exercise

EXPERIMENTAL

low-intensity exercise session followed by a high-intensity exercise session separated by a minimum of 14 days

Other: LOOther: HI

high-intensity exercise - low-intensity exercise

EXPERIMENTAL

high-intensity exercise session followed by a low-intensity exercise session separated by a minimum of 14 days

Other: LOOther: HI

Interventions

LOOTHER

Participants will perform an acute bout of low-intensity cycling (11 x 1 min intervals at \~73% of peak aerobic work rate interspersed with 1 min recovery periods)

high-intensity exercise - low-intensity exerciselow-intensity exercise - high-intensity exercise
HIOTHER

Participants will perform an acute bout of high-intensity cycling (8 x 1 min intervals at \~100% of peak aerobic work rate interspersed with 1 min recovery periods)

high-intensity exercise - low-intensity exerciselow-intensity exercise - high-intensity exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • recreationally active (no more than three hours of structured weekly physical activity)
  • not currently involved in a systematic training program for improving cardiorespiratory fitness, muscular strength, and/or sport-specific skills
  • body mass index \< 30 kg/m2

You may not qualify if:

  • presence of cardiometabolic disease
  • taking regular prescription medication for the treatment of cardiometabolic disease
  • current cigarette smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Health Studies

Kingston, Ontario, K7L3N6, Canada

RECRUITING

Study Officials

  • Brendon J. Gurd, PhD

    School of Kinesiology and Health Studies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hashim Islam, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 5, 2019

Study Start

June 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations