- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473297
A Pilot Study on Skeletal Muscle Proteome Dynamics in Younger and Older Men Undertaking Normal Activity or Resistance Exercise Training. (LHMA Pilot)
Proteome Dynamics to Inform Healthy Muscle Ageing
Study Overview
Detailed Description
Experimental Intervention Baseline muscle biopsy On day -1 of the experimental intervention (around 7 days after the initial assessment), you will need to arrive at the laboratory at ~8 am after an overnight fast. A blood sample (7 ml) will be collected via venipuncture and muscle samples will be collected by percutaneous biopsy of the vastus lateralis (quadriceps) of each leg (see below for more detail).
Deuterium Oxide consumption On the next day (Experiment Day 0) you will consume the stable isotope, deuterium oxide (D2O - see below for more details), which is a tracer that can be used to measure the turnover rate of proteins inside you muscle. You will consume a dose of 13.3 ml D2O per kg body weight on Day 0. This equates to ~1 L of liquid for a person of 75 kg body weight. The liquid must be consumed in 4 doses of ~250 ml each at 2 h intervals, during which time you will be monitored for potential side effect (see below) by the research team, this means you will need to be available for 6 h on this day. (N.B. during this period you will have access to office and catering facilities on the LJMU Byrom Street site). On subsequent days of the experiment you will need to consume one maintenance dose of 0.67 ml D2O per Kg body weight (e.g. 50 ml for a person of 75 kg body weight) - self-administered each day, at a standardised time of day until day 14.
Unilateral leg-press exercise On days 1, 4, 7, 10 and 13 of the experimental intervention, you will perform supervised single-legged resistance exercise (unilateral leg-press) at a standardised time of day. Each session will begin with a warm-up consisting of 5 repetitions at 70 % of 10RM. You will then perform three sets of 10 repetitions at a lifting intensity of 90 % of 10 RM with 2- to 3-min rest between sets. On days 1 and 7 we will collect a venous blood sample (7 ml) and a finger-prick blood sample (~0.2 ml).
Post-intervention muscle biopsy On day 15 of the experimental intervention, you will arrive at the laboratory at 8 am after an overnight fast. A blood sample (7 ml) will be collected via venipuncture and muscle samples will be collected by percutaneous biopsy of the vastus lateralis (quadriceps) of each leg.
Post-intervention muscle function test On day 18 of the experimental intervention, isokinetic torque of the knee extensor muscles will be assessed via isokinetic dynamometry (IKD). Consistent with the initial assessment (Experiment day -7), you will first perform a warm-up (5 min at 50 W on a cycle ergometer) and then complete a test protocol consisting of four consecutive maximal knee extension movements of each leg at two different fixed movement velocities, 1.05 rad.sec-1 (60 deg.sec-1) and 3.14 rad·sec-1 (180 deg.sec-1) from which peak torque (Nm) data will be recorded. This assessment will be scheduled at a time of day roughly equivalent to that of your initial visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Liverpool John Moores University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male
- Age 25-35 OR 65-75 years
Exclusion Criteria:
- female
- take part in >3 bouts of endurance/resistance based training per week
- are pregnant
- have any previous diagnosis of ischaemic heart disease, diabetes mellitus myopathy or any neuromuscular disorder.
- take any anticoagulant medications such as warfarin
- have a current musculoskeletal injury.
- currently unwell with cold or flu
- have a chronic connective tissue disorder
- have a cardiovascular disease
- are currently enrolled in any other research study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Unilateral resistance exercise training
Unilateral resistance exercise of the dominant leg using leg press exercise
|
Unilateral leg press.
Participants undertook a supervised training session of unilateral leg-press exercise at a standardized time of day.
During each session, participants performed a warm-up consisting of 5 repetitions at 70 % of 10RM.
Participants performed three sets of 10 repetitions at a lifting intensity of 90 % of 10 RM with 2- to 3-min rest between sets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle proteome dynamics
Time Frame: Throughout the 14 day intervention period of unilateral leg press exercise.
|
Assessment of muscle proteome quality using dynamic proteome profiling to measure the abundances and turnover rates of muscle proteins.
|
Throughout the 14 day intervention period of unilateral leg press exercise.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22/SPS/075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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