The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
1 other identifier
interventional
24
1 country
1
Brief Summary
The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Apr 2019
Longer than P75 for not_applicable healthy
1 active site
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
Study Start
First participant enrolled
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedMarch 22, 2023
March 1, 2023
11 months
April 16, 2019
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Muscle protein breakdown rate
Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion
1 hour
Secondary Outcomes (2)
Muscle protein breakdown rate
3 hours
Muscle protein synthesis rate
3 hours
Study Arms (2)
Postabsorptive
ACTIVE COMPARATORSaline infusion to mimic postabsorptive circulating amino acid concentrations
Postprandial
ACTIVE COMPARATORAmino acid infusion to mimic postprandial circulating amino acid concentrations
Interventions
Saline will be infused to mimic postabsorptive circulating amino acid concentrations
An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations
One leg will undergo 2 days immobilisation prior to the test day
Eligibility Criteria
You may qualify if:
- Male
- years of age
- Body mass index between 18.5 and 30
You may not qualify if:
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)
- A personal or family history of epilepsy, seizures or schizophrenia
- Any known disorders in muscle metabolism
- Regular use of nutritional supplements
- Allergy to lidocaine
- Allergy to one or multiple amino acids
- Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture) as these could be exacerbated by the intervention e.g. unilateral leg immobilisation, or mean the participant is unable to use crutches.
- Having received or ingested a stable isotope tracer in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlou Dirks, PhD
University of Exeter
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2019
First Posted
May 2, 2019
Study Start
April 15, 2019
Primary Completion
March 17, 2020
Study Completion
January 9, 2023
Last Updated
March 22, 2023
Record last verified: 2023-03