Muscle AtrophyNCT05314413
Examining Sex-based Differences in Metabolic and Mechanistic Responses to Disuse Induced Muscle Atrophy
A study testing Single Leg Immobilization in people with Muscle Atrophy and Muscle Disuse Atrophy, run by McGill University at 1 site in Canada.
Trial summary
The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Muscle Disuse Atrophy
- What is being tested?
- Single Leg Immobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 15 Nov 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35 years inclusive
- Healthy, recreationally active (active for >5 hours/ week)
- Having given informed consent
Who cannot join
- Type I or Type II diabetes
- Highly trained (active for > 15 hours/week)
- Lower limb and/or back injuries in the last 6 months
- A history of thrombosis / cardiovascular disease
- Use of anticoagulants
- Musculoskeletal / orthopedic disorders
Show all 10Show fewer
- Use of tobacco products
- Using medications known to modulate skeletal muscle metabolism including corticosteroids, hormone replacement therapy (HRT), non-steroidal anti-inflammatory drugs (i.e. paracetamol) and over-the-counter supplements including protein powder, creatine monohydrate, and fish oil
- Pregnant
- Currently participating in another clinical trial/ physical intervention research study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans.
Read the detailed description
Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, resulting in physical impairment or lower quality of life during the recovery phase. When measured as maximal isometric contraction, muscle strength in the immobilized limb decreases at a dramatic rate, around 1.0-1.2%/day. These declines in muscle size and strength may vary between sexes - this remains unclear. Muscle atrophy is thought to be caused by a significant decline in muscle protein synthesis (the main pathway attributing to muscle growth/ hypertrophy). There are also various pathways by which muscle is broken down. It is the sex-based differences in this muscle protein synthesis rate of decline and the pathway by which muscle is broken down that we would like to investigate for their contribution to muscle size and strength decline after a period of immobilization.
The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans.
On the participant's first visit, prior to beginning the study (Day 0), they will be instructed to fill out a health-related questionnaire, screened for all anthropometric characteristics (height, weight, age, sex) and undergo a DXA scan for body composition details. They will be familiarized with all study procedures including the muscle biopsies, strength tests, D2O, diet and exercise recording. They will also be fitted for the immobilization brace. The leg that will be immobilized will be randomized in each participant. This first visit will last approximately 2 hours. When participants return on Day 1 of the study, they will first have a lower-body MRI scan done. Following this, participants will perform single-leg strength tests on the Biodex. Thereafter on Day 2, venous blood draws and saliva samples will be taken. Participants will be administered their loading dose of D2O (5mL·kg body mass-1 of 70% D2O) and provided with daily maintenance doses of 50mL of D2O to continue to take each day for the duration of the experiment. Upon returning for Day 3, participants will undergo a single skeletal muscle biopsy from the vastus lateralis of one leg. Participants will repeat their blood and saliva sample on this day. Participants will then be outfitted with the knee brace and crutches prior to leaving the facility. Participants will also be outfitted with an ActiGraph activity monitor to record physical activity and energy expenditure while they are immobilized for 7 days. This third visit will last approximately 3 hours. Participants will monitor their own dietary intake via diet recording, which they will be instructed to carry out for 2 weekdays (i.e. Monday - Friday) and one weekend day (i.e. Saturday, Sunday). During the 7-day period of immobilization, participants will provide a saliva sample every day for measurement of 2H enrichment in body water. The saliva samples should be taken in the morning right after the participants wake up and before any food intake. Participants should drink the 1 × 50 mL maintenance dose of D2O per day provided right after collecting their saliva samples. On Day 8 participants will return to the facility to undergo post-immobilization testing which will include: a DXA scan, a lower-body MRI, two skeletal muscle biopsies (one in each leg), a blood sample, a saliva sample, and single-leg strength tests on both legs. This final visit will last approximately 4 hours.
- Conditions
- Muscle Atrophy, Muscle Disuse Atrophy
- Being tested
- Single Leg Immobilization
- Keywords
- Immobilization
- Medical subject headings
- Muscular Atrophy, Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Leg ImmobilizationProcedure or surgery
7-days of single leg immobilization to induce muscle atrophy
| Study group | Role | What they receive |
|---|---|---|
| Single Leg Immobilization - Males | Experimental | Males will be subjected to 7-days of single-leg immobilization. Receives: Procedure: Single Leg Immobilization |
| Single Leg Immobilization - Females | Experimental | Females will be subjected to 7-days of single-leg immobilization. Receives: Procedure: Single Leg Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional muscle protein synthesis rate
Integrative fractional muscle protein synthesis rates in the immobilized and non-immobilized leg
Measured: Integrative fractional muscle protein synthesis rates over 7 days
Secondary outcomes (4)
Muscle size
Changes in muscle size, measured pre and post immobilization
Measured: Baseline and 7 days
Muscle strength
Changes in muscle strength, measured pre and post immobilization
Measured: Baseline and 7 days
mRNA expression
Changes in mRNA gene expression of specific biomarkers pertaining to skeletal muscle atrophy, measured pre and post immobilization
Measured: Baseline and 7 days
Protein abundance and phosphorylation
Changes in protein abundance and phosphorylation status of select proteins involved in muscle protein synthesis and breakdown, measured pre and post immobilization
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Nov 2022
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314413
- Sponsor's protocol ID
- A00-M05-22B
- Status last verified
- Nov 2024
- First submitted
- 30 Mar 2022
- Last updated
- 25 Nov 2024
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Sex-based Differences in Metabolic and Mechanistic Responses to Disuse Induced Muscle Atrophy
- ClinicalTrials.gov ID
- NCT05314413
- Acronym / sponsor ID
- A00-M05-22B
- Conditions
- Muscle Atrophy, Muscle Disuse Atrophy
- Keywords
- Immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 6 Apr 2022 (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.
The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans.
Detailed description
Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, resulting in physical impairment or lower quality of life during the recovery phase. When measured as maximal isometric contraction, muscle strength in the immobilized limb decreases at a dramatic rate, around 1.0-1.2%/day. These declines in muscle size and strength may vary between sexes - this remains unclear. Muscle atrophy is thought to be caused by a significant decline in muscle protein synthesis (the main pathway attributing to muscle growth/ hypertrophy). There are also various pathways by which muscle is broken down. It is the sex-based differences in this muscle protein synthesis rate of decline and the pathway by which muscle is broken down that we would like to investigate for their contribution to muscle size and strength decline after a period of immobilization.
The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans.
On the participant's first visit, prior to beginning the study (Day 0), they will be instructed to fill out a health-related questionnaire, screened for all anthropometric characteristics (height, weight, age, sex) and undergo a DXA scan for body composition details. They will be familiarized with all study procedures including the muscle biopsies, strength tests, D2O, diet and exercise recording. They will also be fitted for the immobilization brace. The leg that will be immobilized will be randomized in each participant. This first visit will last approximately 2 hours. When participants return on Day 1 of the study, they will first have a lower-body MRI scan done. Following this, participants will perform single-leg strength tests on the Biodex. Thereafter on Day 2, venous blood draws and saliva samples will be taken. Participants will be administered their loading dose of D2O (5mL·kg body mass-1 of 70% D2O) and provided with daily maintenance doses of 50mL of D2O to continue to take each day for the duration of the experiment. Upon returning for Day 3, participants will undergo a single skeletal muscle biopsy from the vastus lateralis of one leg. Participants will repeat their blood and saliva sample on this day. Participants will then be outfitted with the knee brace and crutches prior to leaving the facility. Participants will also be outfitted with an ActiGraph activity monitor to record physical activity and energy expenditure while they are immobilized for 7 days. This third visit will last approximately 3 hours. Participants will monitor their own dietary intake via diet recording, which they will be instructed to carry out for 2 weekdays (i.e. Monday - Friday) and one weekend day (i.e. Saturday, Sunday). During the 7-day period of immobilization, participants will provide a saliva sample every day for measurement of 2H enrichment in body water. The saliva samples should be taken in the morning right after the participants wake up and before any food intake. Participants should drink the 1 × 50 mL maintenance dose of D2O per day provided right after collecting their saliva samples. On Day 8 participants will return to the facility to undergo post-immobilization testing which will include: a DXA scan, a lower-body MRI, two skeletal muscle biopsies (one in each leg), a blood sample, a saliva sample, and single-leg strength tests on both legs. This final visit will last approximately 4 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Leg Immobilization - Males | Experimental | Procedure: Single Leg ImmobilizationMales will be subjected to 7-days of single-leg immobilization. |
| Single Leg Immobilization - Females | Experimental | Procedure: Single Leg ImmobilizationFemales will be subjected to 7-days of single-leg immobilization. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18-35 years inclusive
- Healthy, recreationally active (active for >5 hours/ week)
- Having given informed consent
Key exclusion criteria (10 listed)
- Type I or Type II diabetes
- Highly trained (active for > 15 hours/week)
- Lower limb and/or back injuries in the last 6 months
- A history of thrombosis / cardiovascular disease
- Use of anticoagulants
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 |
|---|---|---|
| Single Leg Immobilization7-days of single leg immobilization to induce muscle atrophy | Procedure or surgery | Single Leg Immobilization - Females, Single Leg Immobilization - Males |
Primary outcome
Fractional muscle protein synthesis rate
Time frame: Integrative fractional muscle protein synthesis rates over 7 days
Integrative fractional muscle protein synthesis rates in the immobilized and non-immobilized leg
4 secondary outcomes
Muscle size
Time frame: Baseline and 7 days
Muscle strength
Time frame: Baseline and 7 days
mRNA expression
Time frame: Baseline and 7 days
Protein abundance and phosphorylation
Time frame: Baseline and 7 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 25 Nov 2024.
- 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 Single Leg Immobilization in people with Muscle Atrophy and Muscle Disuse Atrophy, run by McGill 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 3 inclusion and 10 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 25 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?
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?
Fractional muscle protein synthesis rate (time frame: Integrative fractional muscle protein synthesis rates over 7 days). 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 25 Nov 2024.