ProteomicsHYPATNCT04514744
Dynamic Proteomics and Integrated Rates of Muscle Protein Synthesis During an Acute Period of Loading and Unloading
A study testing Knee bracing and Unilateral Resistance Exercise Training in people with Proteomics and Exercise, run by McMaster University at 1 site in Canada.
Trial summary
Skeletal muscle plays several different roles in the promotion and maintenance of health and well-being. The loss of muscle mass that occurs with aging, chronic muscle wasting diseases, and physical inactivity puts people at an increased risk of frailty and becoming insulin resistant, and therefore imposes 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
- Proteomics, Exercise, Atrophy, Disuse
- What is being tested?
- Knee bracing and Unilateral Resistance Exercise Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2021to 1 Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, between the ages of 18 and 30 y
- Body Mass Index between 18.5 and 30.0 kg/m2
- Able and willing to provide informed consent
Who cannot join
- A history of neuromuscular disorders or muscle/bone wasting diseases.
- Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire.
- The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.).
- A (family) history of thrombosis.
- The use of anticoagulant medications.
- Consumption of tobacco-containing products.
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- Excessive alcohol consumption (>21 units/wk).
- History of bleeding diathesis, platelet or coagulation disorders, or anti-platelet/anticoagulation therapy.
- Exercise participation >2 days/wk (structured resistance and/or aerobic-type exercise)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Dynamic Proteomics and Integrated Rates of Muscle Protein Synthesis During an Acute Period of Hypertrophy and Atrophy (HYPAT) in Young, Healthy Men
Skeletal muscle plays several different roles in the promotion and maintenance of health and well-being. The loss of muscle mass that occurs with aging, chronic muscle wasting diseases, and physical inactivity puts people at an increased risk of frailty and becoming insulin resistant, and therefore imposes a significant burden on health care spending. Resistance exercise participation has proven particularly effective for increasing muscle mass and strength. This effectiveness can be used by health care practitioners in a rehabilitation setting to promote the recovery of individuals who have undergone involuntary periods of muscular unloading (i.e. limb immobilization caused by a sports injury or reconstructive surgery). However, there is large variability in the amount of muscle mass and strength that people gain following participation in resistance exercise. Some individuals fail to increase the size of their muscle (low responders) whereas others show vary large increases in muscle size (high responders) in response to the same resistance training program. People also show differences in the amount of muscle tissue they lose when they have a limb immobilized. To circumvent variability across individuals, the investigators utilized a within-person paired Hypertrophy and Atrophy ('HYPAT') strategy that reduced response heterogeneity by ~40% (Available at: https://ssrn.com/abstract=3445673). Specifically, one leg performed resistance training for 10 weeks to induce hypertrophy, whereas the other leg underwent single-leg immobilization for 2 weeks to induce atrophy. The primary goal of the study will be to gain insight into the molecular responses to an acute period of single-leg immobilization and resistance exercise (8 days). The investigators will use an integrated systems biology approach to monitor the individual rates of over one hundred different muscle proteins.
- Conditions
- Proteomics, Exercise, Atrophy, Disuse, Hypertrophy
- Being tested
- Knee bracing, Unilateral Resistance Exercise Training
- Medical subject headings
- Motor Activity, Muscular Disorders, Atrophic, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee bracingProcedure or surgery
Participants will have one leg immobilized, by means of a removable Don Joy Knee Brace. Participants will be expected to keep the knee brace on for 14 days, completely prevent weight bearing on the immobilized leg, and use crutches.
Unilateral Resistance Exercise TrainingOther
Participants will perform resistance training on 4 occasions throughout an 8 day time period.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Immobilization | Experimental | One leg will undergo 14 days of single-leg immobilization, by means of a removable knee brace. Receives: Procedure: Knee bracing |
| Unilateral Resistance Exercise | Experimental | One leg will undergo 4 sessions of unilateral resistance exercise, over the course of 8 days. Specifically, participants will be asked to perform leg press and leg extension. Receives: Other: Unilateral Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dynamic Proteomics
The investigators will use deuterated water and skeletal muscle biopsies, paired with sensitive Gas Chromatography-Mass Spectrometry techniques to calculate the individual synthesis rate of over one hundred different skeletal muscle proteins.
Measured: Baseline, Day 5, Day 9 and Day 14 (Post)
Change in Integrated Rates of Muscle Protein Synthesis
The investigators will use deuterated water and skeletal muscle biopsies to calculate the cumulative synthesis of skeletal muscle proteins.
Measured: Baseline, Day 5, Day 9 and Day 14 (Post)
Secondary outcomes (3)
Change in Lean Mass Using Dual X-Ray Absorptiometry
The change in lean mass (kg) will be assessed throughout the intervention using dual X-Ray absorptiometry at baseline, Day 4, and Day 8 (Post) of the intervention
Measured: Baseline, Day 5 and Day 14 (Post)
Change in Muscle Strength using an Isokinetic Dynamometer
Muscle strength will be analyzed throughout the intervention using an isokinetic dynamometer. Isometric muscle torque (i.e., strength [N*m]) of the knee extensor will be measured.
Measured: Baseline, Day 5 and Day 14 (Post)
Change in Muscle Cross-Sectional Area using Ultrasonography
The investigators will measure changes in vastus lateralis muscle cross sectional area (cm^2) throughout the intervention using ultrasonography.
Measured: Baseline, Day 5 and Day 14 (Post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start30 Dec 2021
- Primary completion1 Sep 2022
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteomicsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a randomized fashion, one participant will have one leg assigned to unilateral immobilization, and the other leg will undergo unilateral resistance exercise training, for 8 days.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514744
- Sponsor's protocol ID
- 10624
- Acronym
- HYPAT
- Status last verified
- Oct 2024
- First submitted
- 29 Jun 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Proteomics and Integrated Rates of Muscle Protein Synthesis During an Acute Period of Hypertrophy and Atrophy (HYPAT) in Young, Healthy Men
- ClinicalTrials.gov ID
- NCT04514744
- Acronym / sponsor ID
- HYPAT / 10624
- Conditions
- Proteomics, Exercise, Atrophy, Disuse, Hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Aug 2020 (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 several different roles in the promotion and maintenance of health and well-being. The loss of muscle mass that occurs with aging, chronic muscle wasting diseases, and physical inactivity puts people at an increased risk of frailty and becoming insulin resistant, and therefore imposes a significant burden on health care spending. Resistance exercise participation has proven particularly effective for increasing muscle mass and strength. This effectiveness can be used by health care practitioners in a rehabilitation setting to promote the recovery of individuals who have undergone involuntary periods of muscular unloading (i.e. limb immobilization caused by a sports injury or reconstructive surgery). However, there is large variability in the amount of muscle mass and strength that people gain following participation in resistance exercise. Some individuals fail to increase the size of their muscle (low responders) whereas others show vary large increases in muscle size (high responders) in response to the same resistance training program. People also show differences in the amount of muscle tissue they lose when they have a limb immobilized. To circumvent variability across individuals, the investigators utilized a within-person paired Hypertrophy and Atrophy ('HYPAT') strategy that reduced response heterogeneity by ~40% (Available at: https://ssrn.com/abstract=3445673). Specifically, one leg performed resistance training for 10 weeks to induce hypertrophy, whereas the other leg underwent single-leg immobilization for 2 weeks to induce atrophy. The primary goal of the study will be to gain insight into the molecular responses to an acute period of single-leg immobilization and resistance exercise (8 days). The investigators will use an integrated systems biology approach to monitor the individual rates of over one hundred different muscle proteins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a randomized fashion, one participant will have one leg assigned to unilateral immobilization, and the other leg will undergo unilateral resistance exercise training, for 8 days.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Immobilization | Experimental | Procedure: Knee bracingOne leg will undergo 14 days of single-leg immobilization, by means of a removable knee brace. |
| Unilateral Resistance Exercise | Experimental | Other: Unilateral Resistance Exercise TrainingOne leg will undergo 4 sessions of unilateral resistance exercise, over the course of 8 days. Specifically, participants will be asked to perform leg press and leg extension. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males, between the ages of 18 and 30 y
- Body Mass Index between 18.5 and 30.0 kg/m2
- Able and willing to provide informed consent
Key exclusion criteria (9 listed)
- A history of neuromuscular disorders or muscle/bone wasting diseases.
- Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire.
- The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.).
- A (family) history of thrombosis.
- The use of anticoagulant medications.
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 |
|---|---|---|
| Knee bracingParticipants will have one leg immobilized, by means of a removable Don Joy Knee Brace. Participants will be expected to keep the knee brace on for 14 days, completely prevent weight bearing on the immobilized leg, and use crutches. | Procedure or surgery | Unilateral Immobilization |
| Unilateral Resistance Exercise TrainingParticipants will perform resistance training on 4 occasions throughout an 8 day time period. | Other | Unilateral Resistance Exercise |
Primary outcome
Change in Dynamic Proteomics
Time frame: Baseline, Day 5, Day 9 and Day 14 (Post)
The investigators will use deuterated water and skeletal muscle biopsies, paired with sensitive Gas Chromatography-Mass Spectrometry techniques to calculate the individual synthesis rate of over one hundred different skeletal muscle proteins.
Change in Integrated Rates of Muscle Protein Synthesis
Time frame: Baseline, Day 5, Day 9 and Day 14 (Post)
The investigators will use deuterated water and skeletal muscle biopsies to calculate the cumulative synthesis of skeletal muscle proteins.
3 secondary outcomes
Change in Lean Mass Using Dual X-Ray Absorptiometry
Time frame: Baseline, Day 5 and Day 14 (Post)
Change in Muscle Strength using an Isokinetic Dynamometer
Time frame: Baseline, Day 5 and Day 14 (Post)
Change in Muscle Cross-Sectional Area using Ultrasonography
Time frame: Baseline, Day 5 and Day 14 (Post)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No. All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.
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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 Knee bracing and Unilateral Resistance Exercise Training in people with Proteomics and Exercise, 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 3 inclusion and 9 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 2 Oct 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?
Results are not available in the source record.
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 Dynamic Proteomics (time frame: Baseline, Day 5, Day 9 and Day 14 (Post)). 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 2 Oct 2024.