Skeletal Muscle Protein SynthesisNCT04263714
Effect of Exercise on the Human Skeletal Muscle Phosphoproteome
A study testing Exercise in people with Skeletal Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
Trial summary
Generally, resistance exercise increases muscle mass and strength, and fatigue resistance. How resistance exercise achieves these adaptations remains understudied, but what is known is that skeletal muscle translates the physical and biochemical stresses of resistance exercise into morphological and metabolic… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Protein Synthesis
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18 and 30 years
Who cannot join
- Smoker or user of tobacco products;
- High physical activity
- Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which you are being treated that might put you at risk for this study;
- Taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications;
- Use of an investigational drug product within the last 30 days;
- Have participated in an infusion protocol in the last year; or
- Do not understand English or have a condition the PI believes would interfere with a participants' ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put someone at undue risk.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Generally, resistance exercise increases muscle mass and strength, and fatigue resistance. How resistance exercise achieves these adaptations remains understudied, but what is known is that skeletal muscle translates the physical and biochemical stresses of resistance exercise into morphological and metabolic adaptations. While resistance exercise activates signaling pathways (i.e., proteins) that increase the synthesis of specific proteins to cause adaptations, thousands of proteins are likely involved, and their interactions are complicated. The investigators aim to study these processes.
Read the detailed description
Skeletal muscle is a highly plastic tissue, capable of adapting to changes in nutritional intake and contractile activity. For instance, resistance exercise results in a mild stimulation of rates of muscle protein breakdown (MPB) but a greater stimulation of the rates of muscle protein synthesis (MPS). When resistance exercise is performed prior to protein ingestion there is a synergistic combination of the two stimuli such that rates of MPS are stimulated over and above those of MPB. Thus, repeated bouts of resistance exercise, when coupled with protein ingestion, result in the accretion of skeletal muscle protein referred to as hypertrophy. Importantly, by changing the nature of the exercise stimulus, it is possible to redirect the focus of the type of skeletal muscle proteins that are being synthesized. For example, prolonged and repeated lower-load dynamic stimulation of skeletal muscle (i.e., endurance exercise training) results in an increase in the expression of mitochondrial genes, proteins, and ultimately enhanced mitochondrial content, leading to a shift towards an oxidative phenotype, and improved fatigue resistance. Resistance exercise training also stimulates the transcription of genes and accrual of new muscle proteins, but these genes and proteins are largely associated with the myofibrillar protein fraction, and regular resistance exercise leads to muscle hypertrophy and increased force-generating capacity. However, during the early stages of exercise training, particularly in training-naïve participants there is a significant increase in the expression of genes common to both modalities of exercise. It is only with sustained exercise training that there is a 'fine-tuning' of the transcriptome, the protein synthetic response, and then the proteome that gives rise to divergent hypertrophic and oxidative phenotypes.
- Conditions
- Skeletal Muscle Protein Synthesis
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Aerobic exercise and resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | All subjects will perform both aerobic and resistance exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acute Muscle Protein Synthesis
Myofibrillar and intracellular enrichments of L-[ring- 13C6] phenylalanine will be measured. MPS will be calculated using the precursor-product equation: MPS =([E2b-E1b]/[Eic x t]) x 100. Eb represents the enrichment of bound myofibrillar protein, Eic is the average intracellular enrichment between two biopsies, and t is the tracer incorporation time in h. As we will employ 'tracer naïve' participants (had not previously participated in a study protocol where L-[ring- 13C6] phenylalanine was infused), a pre-infusion blood sample will be used for the calculation of resting myofibrillar MPS. The outcomes measure will be expressed as a percentage change of MPS relative to the baseline measure. i.e. intracellular enrichment of L-[ring- 13C6] phenylalanine relative to the baseline (resting) period.
Measured: Pre exercise (resting) to 3 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 posted11 Feb 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skeletal Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Aerobic and resistance exercise
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University, Department of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263714
- Sponsor's protocol ID
- 2196
- Status last verified
- Nov 2024
- First submitted
- 5 Feb 2020
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be deposited on OSF
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on the Human Skeletal Muscle Phosphoproteome
- ClinicalTrials.gov ID
- NCT04263714
- Acronym / sponsor ID
- 2196
- Conditions
- Skeletal Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Generally, resistance exercise increases muscle mass and strength, and fatigue resistance. How resistance exercise achieves these adaptations remains understudied, but what is known is that skeletal muscle translates the physical and biochemical stresses of resistance exercise into morphological and metabolic adaptations. While resistance exercise activates signaling pathways (i.e., proteins) that increase the synthesis of specific proteins to cause adaptations, thousands of proteins are likely involved, and their interactions are complicated. The investigators aim to study these processes.
Detailed description
Skeletal muscle is a highly plastic tissue, capable of adapting to changes in nutritional intake and contractile activity. For instance, resistance exercise results in a mild stimulation of rates of muscle protein breakdown (MPB) but a greater stimulation of the rates of muscle protein synthesis (MPS). When resistance exercise is performed prior to protein ingestion there is a synergistic combination of the two stimuli such that rates of MPS are stimulated over and above those of MPB. Thus, repeated bouts of resistance exercise, when coupled with protein ingestion, result in the accretion of skeletal muscle protein referred to as hypertrophy. Importantly, by changing the nature of the exercise stimulus, it is possible to redirect the focus of the type of skeletal muscle proteins that are being synthesized. For example, prolonged and repeated lower-load dynamic stimulation of skeletal muscle (i.e., endurance exercise training) results in an increase in the expression of mitochondrial genes, proteins, and ultimately enhanced mitochondrial content, leading to a shift towards an oxidative phenotype, and improved fatigue resistance. Resistance exercise training also stimulates the transcription of genes and accrual of new muscle proteins, but these genes and proteins are largely associated with the myofibrillar protein fraction, and regular resistance exercise leads to muscle hypertrophy and increased force-generating capacity. However, during the early stages of exercise training, particularly in training-naïve participants there is a significant increase in the expression of genes common to both modalities of exercise. It is only with sustained exercise training that there is a 'fine-tuning' of the transcriptome, the protein synthetic response, and then the proteome that gives rise to divergent hypertrophic and oxidative phenotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Aerobic and resistance exercise
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseAll subjects will perform both aerobic and resistance exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- between the ages of 18 and 30 years
Key exclusion criteria (7 listed)
- Smoker or user of tobacco products;
- High physical activity
- Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which you are being treated that might put you at risk for this study;
- Taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications;
- Use of an investigational drug product within the last 30 days;
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 |
|---|---|---|
| ExerciseAerobic exercise and resistance exercise | Behavioural | Exercise |
Primary outcome
Change in Acute Muscle Protein Synthesis
Time frame: Pre exercise (resting) to 3 hours post-exercise
Myofibrillar and intracellular enrichments of L-[ring- 13C6] phenylalanine will be measured. MPS will be calculated using the precursor-product equation: MPS =([E2b-E1b]/[Eic x t]) x 100. Eb represents the enrichment of bound myofibrillar protein, Eic is the average intracellular enrichment between two biopsies, and t is the tracer incorporation time in h. As we will employ 'tracer naïve' participants (had not previously participated in a study protocol where L-[ring- 13C6] phenylalanine was infused), a pre-infusion blood sample will be used for the calculation of resting myofibrillar MPS. The outcomes measure will be expressed as a percentage change of MPS relative to the baseline measure. i.e. intracellular enrichment of L-[ring- 13C6] phenylalanine relative to the baseline (resting) period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data will be deposited on OSF
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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.
Stuart Phillips, PhD principal investigator
McMaster University, Department of Kinesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Skeletal Muscle Protein Synthesis, run by McMaster University 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 21 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acute Muscle Protein Synthesis (time frame: Pre exercise (resting) to 3 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 21 Nov 2024.