NCT06350591

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2025

Completed
Last Updated

October 1, 2025

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

January 16, 2024

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    -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.

    -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

    0 (-4, 0, and 4 hours), and 10 days

  • Muscle torque

    -6 and 10 days

  • Quadriceps skeletal muscle volume

    0 and 10 days

Study Arms (2)

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.

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).

Other: Resistance training

Interventions

single-leg immobilization

Immobilization

Leg extension and leg press; 3 sets of 8-12 reps

Resistance Training

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Health Studies

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

ImmobilizationResistance Training

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: parallel, within-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2024

First Posted

April 5, 2024

Study Start

April 1, 2024

Primary Completion

March 11, 2025

Study Completion

March 11, 2025

Last Updated

October 1, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations