AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Canada1 site
  • Currie Gynasium 309 - McGill University

    Montreal, Quebec, H2W 1S4

Other trials in Canada

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.

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 groups in NCT05314413
Study groupRoleWhat they receive
Single Leg Immobilization - MalesExperimentalMales will be subjected to 7-days of single-leg immobilization.
Receives: Procedure: Single Leg Immobilization
Single Leg Immobilization - FemalesExperimentalFemales 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.

  1. 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)
  1. Muscle size

    Changes in muscle size, measured pre and post immobilization

    Measured: Baseline and 7 days

  2. Muscle strength

    Changes in muscle strength, measured pre and post immobilization

    Measured: Baseline and 7 days

  3. 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

  4. 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.

  1. First posted6 Apr 2022
  2. Study start1 Nov 2022
  3. Primary completion15 Nov 2024
  4. Study completion15 Nov 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in