Mitochondrial BiogenesisNCT03975777
Time-course of Mitochondrial Biogenic Gene and Protein Expression in Exercised Human Skeletal Muscle
A study testing LO and HI in people with Mitochondrial Biogenesis, run by Brendon Gurd, PhD at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Biogenesis
- What is being tested?
- LO and HI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 30 Apr 2020
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- presence of cardiometabolic disease
- taking regular prescription medication for the treatment of cardiometabolic disease
- current cigarette smoker
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
School of Kinesiology and Health Studies
Kingston, Ontario, K7L3N6
Hashim Islam, MSc, 4037954125, 16mhi@queensu.ca
About this study
Official title: Impact of Exercise Intensity on the Time-course of Mitochondrial Biogenic Gene and Protein Expression in Human Skeletal Muscle.
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.
- Conditions
- Mitochondrial Biogenesis
- Being tested
- LO, HI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: LO; Other: 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 Receives: Other: LO; Other: HI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Secondary outcomes (21)
Change in PGC-1α protein content
PGC-1α protein content
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in nuclear factor-erythroid 2 like 2 (Nrf2) mRNA expression
Nrf2 gene expression (indirect indicator of Nrf2 activity). Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in Nrf2 protein content
Nrf2 protein content
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in PPAR-beta mRNA expression
PPAR-beta gene expression (indirect indicator of PPAR-beta activity). Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in estrogen related receptor (ERR)-gamma mRNA expression
ERR-gamma gene expression. Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in leucine-rich pentatricopeptide repeat containing protein 130 (LRP130) mRNA expression
LRP130 gene expression. Transcriptional co-activator and RNA-binding protein involved in the transcriptional control and stabilization of mitochondrial mRNAs
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in LRP130 protein content
LRP130 protein content
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in nuclear respiratory factor-1 (NRF-1) mRNA expression
NRF-1 gene expression. Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in NRF-1 protein content
NRF-1 protein content
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor A (TFAM) mRNA expression
TFAM gene expression. Transcription factor controlling the expression of mitochondrial-encoded genes.
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in TFAM protein content
TFAM protein content
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in p53 mRNA expression
p53 gene expression. Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in cytochrome c oxidase subunit 4 (COXIV) mRNA expression.
COXIV gene expression. Nuclear encoded subunit of the electron transport chain complex 4 (COX)
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in COXI mRNA expression
COXI gene expression. Mitochondrial encoded subunit of the electron transport chain complex IV (COX)
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in COXII mRNA expression
COXII gene expression.Mitochondrial encoded subunit of the electron transport chain complex IV (COX).
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in nicotinamide adenine dinucleotide (NADH) subunit 1 (ND1) mRNA expression
ND1 gene expression. Mitochondrial encoded subunit of the electron transport chain complex 1 (NADH dehydrogenase)
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in ND4 mRNA expression
ND4 gene expression. Mitochondrial encoded subunit of the electron transport chain complex 1 (NADH dehydrogenase).
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in citrate synthase (CS) mRNA expression
CS gene expression. The first rate limiting enzyme of the Kreb's cycle.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in NRF-2 mRNA expression
NRF-2 gene expression. Transcription factor involved in the control of mitochondrial biogenesis.
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor B1 (TFB1M) mRNA expression
TFB1M gene expression. Transcription factor controlling the expression of mitochondrial-encoded genes.
Measured: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor B2 (TFB2M) mRNA expression
TFB2M gene expression. Transcription factor controlling the expression of mitochondrial-encoded genes.
Measured: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial BiogenesisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brendon Gurd, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brendon Gurd, PhD, Queen's University
- Investigators
- Brendon J. Gurd, PhD, Principal investigator, School of Kinesiology and Health Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975777
- Sponsor's protocol ID
- QMPL-TC-19
- Status last verified
- Mar 2020
- First submitted
- 29 May 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Intensity on the Time-course of Mitochondrial Biogenic Gene and Protein Expression in Human Skeletal Muscle.
- ClinicalTrials.gov ID
- NCT03975777
- Acronym / sponsor ID
- QMPL-TC-19
- Conditions
- Mitochondrial Biogenesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brendon Gurd, PhDUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 5 Jun 2019 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-intensity exercise - high-intensity exercise | Experimental | Other: LO, Other: HIlow-intensity exercise session followed by a high-intensity exercise session separated by a minimum of 14 days |
| high-intensity exercise - low-intensity exercise | Experimental | Other: LO, Other: HIhigh-intensity exercise session followed by a low-intensity exercise session separated by a minimum of 14 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- presence of cardiometabolic disease
- taking regular prescription medication for the treatment of cardiometabolic disease
- current cigarette smoker
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 |
|---|---|---|
| LOParticipants 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) | Other | high-intensity exercise - low-intensity exercise, low-intensity exercise - high-intensity exercise |
| HIParticipants 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) | Other | high-intensity exercise - low-intensity exercise, low-intensity exercise - high-intensity exercise |
Primary outcome
Change in peroxisome proliferator activated receptor (PPAR) gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
PGC-1α gene expression (indirect indicator of PGC-1α activity). Transcriptional co-activator involved in the control of mitochondrial biogenesis.
21 secondary outcomes
Change in PGC-1α protein content
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in nuclear factor-erythroid 2 like 2 (Nrf2) mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in Nrf2 protein content
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in PPAR-beta mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in estrogen related receptor (ERR)-gamma mRNA expression
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in leucine-rich pentatricopeptide repeat containing protein 130 (LRP130) mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in LRP130 protein content
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in nuclear respiratory factor-1 (NRF-1) mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in NRF-1 protein content
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor A (TFAM) mRNA expression
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in TFAM protein content
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in p53 mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in cytochrome c oxidase subunit 4 (COXIV) mRNA expression.
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in COXI mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in COXII mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in nicotinamide adenine dinucleotide (NADH) subunit 1 (ND1) mRNA expression
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in ND4 mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in citrate synthase (CS) mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in NRF-2 mRNA expression
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor B1 (TFB1M) mRNA expression
Time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise
Change in mitochondrial transcription factor B2 (TFB2M) mRNA expression
Time frame: before exercise and 1, 3, 6, 9, and 12 hours post-exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Mitochondrial Biogenesis
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility
Idiopathic Infertility, Infertility Unexplained
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.
Brendon J. Gurd, PhD principal investigator
School of Kinesiology and Health Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LO and HI in people with Mitochondrial Biogenesis, run by Brendon Gurd, PhD at 1 site in Canada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. 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 Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hashim Islam, MSc (4037954125, 16mhi@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peroxisome proliferator activated receptor (PPAR) gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression (time frame: before exercise to 1, 3, 6, 9, and 12 hours post-exercise). 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 4 Mar 2020.