HealthyNCT06350591
Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse
A study testing Immobilization and Resistance training in people with Healthy and Skeletal Muscle Atrophy, run by Queen's University at 1 site in Canada.
Trial summary
Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Skeletal Muscle Atrophy, Skeletal Muscle Hypertrophy
- What is being tested?
- Immobilization and Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 11 Mar 2025
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females 18-30 years
- BMI between 18-28 kg/m2
- ≥2 days per week of structured exercise
- Generally healthy as assessed by medical and physical activity questionnaires
- Participants not currently pregnant
Who cannot join
- Any muscular, neurological, respiratory, or metabolic disease including diabetes
- Any form of cancer currently or in the last 5 years
- Bleeding disorders or antiplatelet / anticoagulation therapy
- Currently taking fish oils or within the last 6 months
- Currently taking any form of steroid or within the last 3 months
- Inability to attain magnetic resonance imaging scans
Show all 11Show fewer
- Known irregular responses to physical activity (e.g., shortness of breath, chest pain, dizziness, etc.)
- Any current illness
- Currently smoking or smoking within the last 6 months
- Currently pregnant
- Any concurrent medical, psychiatric, or orthopedic condition that, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Kinesiology and Health Studies
Kingston, Ontario, K7L 3N6
About this study
Official title: Evaluating Changes in Skeletal Muscle Protein Synthesis, and the Dynamic Proteome, Following Unilateral Resistance Exercise Training and Single-leg Immobilization
Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy.
Read the detailed description
Skeletal muscle is a highly plastic tissue capable of modifying its phenotype (i.e., structural, contractile, and metabolic properties) in response to alterations in mechanical loading. Mechanistically underpinning skeletal muscle plasticity are changes in skeletal muscle protein turnover. Skeletal muscle size is dictated by changes in rates of muscle protein synthesis (MPS) and rates of muscle protein breakdown (MPB) with changes in rates of MPS being the primary determinant of human skeletal muscle mass. Both MPS and MPB are highly sensitive to contractile and nutritional cues. In response to EAA ingestion, there is a rise in rates of MPS and a mild suppression of MPB rates resulting in a positive state of protein balance. Similarly, when an individual performs a bout of resistance exercise, there is an increase in rates of MPS that is potentiated by EAA feeding; It is for this reason that when repeated bouts of resistance exercise are coupled with EAA intake over time, there is a gradual increase in skeletal muscle mass termed hypertrophy. In contrast, when an individual undergoes a reduction in levels of contractile activity (e.g., immobilization due to injury or surgery), there is a reduction in both fed and fasted rates of MPS leading to the loss of skeletal muscle mass and size termed muscle atrophy.
Although it is well known that both nutrition and contractile activity affect rates of muscle protein turnover and skeletal muscle mass, our current knowledge is limited by most studies reporting rates of MPS and MPB that are averages of thousands of proteins in the whole muscle, or subcellular protein fractions, such as myofibrillar, sarcoplasmic, and mitochondrial. Further, individual protein MPS and MPB rates might span a broad range and there may be selective changes to the turnover of individual proteins under different skeletal muscle loading scenarios. Dynamic proteomic profiling (DPP) is an emerging methodology that combines quantitative proteomic abundance measurements with individual protein MPS and MPB rates, to deliver unprecedented insight into the molecular regulation of individual protein turnover. Another major consideration is that nearly all studies in this field have been conducted in males, with limited data in females. The lack of data in females is a major knowledge gap and of major concern particularly given there is evidence that women may display different molecular responses to exercise, nutrition, and disuse compared to men.
The purpose of this investigation is to gain a better understanding of the acute and short-term effects of an EAA supplement and an acute bout of resistance exercise on rates of muscle protein turnover. Further, the investigators aim to measure the dynamic proteome during 10 days of unilateral leg immobilization, and following several bouts of resistance exercise in the contralateral leg, in young healthy women. The present investigation will characterize skeletal muscle mass, strength, protein expression, and protein synthesis rates (individual [i.e., DPP] and average). The study may inform potential future novel interventions to attenuate losses in skeletal muscle mass owing to disuse, aging, or injury.
- Being tested
- Immobilization, Resistance training
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmobilizationOther
single-leg immobilization
Resistance trainingOther
Leg extension and leg press; 3 sets of 8-12 reps
| Study group | Role | What they receive |
|---|---|---|
| Immobilization | Experimental | Participants will undergo 10 days of unilateral immobilization whereby a leg will remain in 60 degrees of flexion with the use of a brace. All participants will complete this protocol. Receives: Other: Immobilization |
| Resistance Training | Experimental | Participants will undergo 4 sessions of unilateral resistance training over a 10 day period (the resistance training protocol will include 3 sets of 8-12 reps of leg press and leg extension). All participants will complete this protocol. On day 0, participants will be asked to undergo a bout of unilateral resistance exercise, and the investigators will assess the acute response to exercise + protein feeding (via EAA supplement). Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in average rates of muscle synthesis
Skeletal muscle amino acids will be isolated and derivatized. Deuterium enrichment into protein-bound alanine will be measured using Gas chromatography-Pyrolysis-Isotope Ratio Mass Spectrometry
Measured: -2, 0 (-4, 0, and 4 hours), and 10 days
Dynamic proteomic profiling
Skeletal muscle lysates containing ~100 ug protein will be digested using sequencing-grade trypsin, and analyzed, via UPLC-QTOF-MS. This will enable the quantification of changes in individual protein abundance, and rates of synthesis and breakdown.
Measured: -2, 0, and 10 days
Secondary outcomes (3)
Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression
Translational factors and novel proteins involved in skeletal muscle protein synthesis (e.g. mTORC1, p70S6K1, Deptor, NID2, FKBP1A, BCAT2, MBNL1, AGO2, LRRC30, and TP53BP1), and mitochondrial function (e.g., ANT1) will be assessed, via western blotting
Measured: 0 (-4, 0, and 4 hours), and 10 days
Muscle torque
Muscle torque will be measured during seated isometric knee extension on a dynamometer
Measured: -6 and 10 days
Quadriceps skeletal muscle volume
Quadriceps muscle volume assessed by magnetic resonance imaging scan.
Measured: 0 and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- parallel, within-subject design
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chris McGlory, PhD, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350591
- Sponsor's protocol ID
- 6038674
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2024
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Changes in Skeletal Muscle Protein Synthesis, and the Dynamic Proteome, Following Unilateral Resistance Exercise Training and Single-leg Immobilization
- ClinicalTrials.gov ID
- NCT06350591
- Acronym / sponsor ID
- 6038674
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 5 Apr 2024 (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.
Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy.
Detailed description
Skeletal muscle is a highly plastic tissue capable of modifying its phenotype (i.e., structural, contractile, and metabolic properties) in response to alterations in mechanical loading. Mechanistically underpinning skeletal muscle plasticity are changes in skeletal muscle protein turnover. Skeletal muscle size is dictated by changes in rates of muscle protein synthesis (MPS) and rates of muscle protein breakdown (MPB) with changes in rates of MPS being the primary determinant of human skeletal muscle mass. Both MPS and MPB are highly sensitive to contractile and nutritional cues. In response to EAA ingestion, there is a rise in rates of MPS and a mild suppression of MPB rates resulting in a positive state of protein balance. Similarly, when an individual performs a bout of resistance exercise, there is an increase in rates of MPS that is potentiated by EAA feeding; It is for this reason that when repeated bouts of resistance exercise are coupled with EAA intake over time, there is a gradual increase in skeletal muscle mass termed hypertrophy. In contrast, when an individual undergoes a reduction in levels of contractile activity (e.g., immobilization due to injury or surgery), there is a reduction in both fed and fasted rates of MPS leading to the loss of skeletal muscle mass and size termed muscle atrophy.
Although it is well known that both nutrition and contractile activity affect rates of muscle protein turnover and skeletal muscle mass, our current knowledge is limited by most studies reporting rates of MPS and MPB that are averages of thousands of proteins in the whole muscle, or subcellular protein fractions, such as myofibrillar, sarcoplasmic, and mitochondrial. Further, individual protein MPS and MPB rates might span a broad range and there may be selective changes to the turnover of individual proteins under different skeletal muscle loading scenarios. Dynamic proteomic profiling (DPP) is an emerging methodology that combines quantitative proteomic abundance measurements with individual protein MPS and MPB rates, to deliver unprecedented insight into the molecular regulation of individual protein turnover. Another major consideration is that nearly all studies in this field have been conducted in males, with limited data in females. The lack of data in females is a major knowledge gap and of major concern particularly given there is evidence that women may display different molecular responses to exercise, nutrition, and disuse compared to men.
The purpose of this investigation is to gain a better understanding of the acute and short-term effects of an EAA supplement and an acute bout of resistance exercise on rates of muscle protein turnover. Further, the investigators aim to measure the dynamic proteome during 10 days of unilateral leg immobilization, and following several bouts of resistance exercise in the contralateral leg, in young healthy women. The present investigation will characterize skeletal muscle mass, strength, protein expression, and protein synthesis rates (individual [i.e., DPP] and average). The study may inform potential future novel interventions to attenuate losses in skeletal muscle mass owing to disuse, aging, or injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel, within-subject design
| Arm | Type | Receives |
|---|---|---|
| Immobilization | Experimental | Other: ImmobilizationParticipants will undergo 10 days of unilateral immobilization whereby a leg will remain in 60 degrees of flexion with the use of a brace. All participants will complete this protocol. |
| Resistance Training | Experimental | Other: Resistance trainingParticipants will undergo 4 sessions of unilateral resistance training over a 10 day period (the resistance training protocol will include 3 sets of 8-12 reps of leg press and leg extension). All participants will complete this protocol. On day 0, participants will be asked to undergo a bout of unilateral resistance exercise, and the investigators will assess the acute response to exercise + protein feeding (via EAA supplement). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females 18-30 years
- BMI between 18-28 kg/m2
- ≥2 days per week of structured exercise
- Generally healthy as assessed by medical and physical activity questionnaires
- Participants not currently pregnant
Key exclusion criteria (11 listed)
- Any muscular, neurological, respiratory, or metabolic disease including diabetes
- Any form of cancer currently or in the last 5 years
- Bleeding disorders or antiplatelet / anticoagulation therapy
- Currently taking fish oils or within the last 6 months
- Currently taking any form of steroid or within the last 3 months
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 |
|---|---|---|
| Immobilizationsingle-leg immobilization | Other | Immobilization |
| Resistance trainingLeg extension and leg press; 3 sets of 8-12 reps | Other | Resistance Training |
Primary outcome
Changes in average rates of muscle synthesis
Time frame: -2, 0 (-4, 0, and 4 hours), and 10 days
Skeletal muscle amino acids will be isolated and derivatized. Deuterium enrichment into protein-bound alanine will be measured using Gas chromatography-Pyrolysis-Isotope Ratio Mass Spectrometry
Dynamic proteomic profiling
Time frame: -2, 0, and 10 days
Skeletal muscle lysates containing ~100 ug protein will be digested using sequencing-grade trypsin, and analyzed, via UPLC-QTOF-MS. This will enable the quantification of changes in individual protein abundance, and rates of synthesis and breakdown.
3 secondary outcomes
Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression
Time frame: 0 (-4, 0, and 4 hours), and 10 days
Muscle torque
Time frame: -6 and 10 days
Quadriceps skeletal muscle volume
Time frame: 0 and 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immobilization and Resistance training in people with Healthy and Skeletal Muscle Atrophy, run by Queen's 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 5 inclusion and 11 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 1 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in average rates of muscle synthesis (time frame: -2, 0 (-4, 0, and 4 hours), and 10 days). The study lists 2 primary outcomes in all. 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 1 Oct 2025.