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The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males

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ClinicalTrials.gov Identifier: NCT03934632
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of Exeter

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Other: Postabsorptive Other: Postprandial Procedure: Immobilisation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : March 17, 2020
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Postabsorptive
Saline infusion to mimic postabsorptive circulating amino acid concentrations
 Other: Postabsorptive
Saline will be infused to mimic postabsorptive circulating amino acid concentrations

Procedure: Immobilisation
One leg will undergo 2 days immobilisation prior to the test day
Active Comparator: Postprandial
Amino acid infusion to mimic postprandial circulating amino acid concentrations
 Other: Postprandial
An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations

Procedure: Immobilisation
One leg will undergo 2 days immobilisation prior to the test day


Outcome Measures
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Primary Outcome Measures :
  1. Muscle protein breakdown rate [ Time Frame: 1 hour ]
    Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion


Secondary Outcome Measures :
  1. Muscle protein breakdown rate [ Time Frame: 3 hours ]
    Muscle protein breakdown rate (FBR, measured in %/h) during 3 hours of saline or amino acid infusion

  2. Muscle protein synthesis rate [ Time Frame: 3 hours ]
    Muscle protein synthesis rate (FSR, measured in %/h) during 3 hours of saline or amino acid infusion measured using a D5 phenylalanine infusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • 18-40 years of age
  • Body mass index between 18.5 and 30

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934632


Locations
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United Kingdom
University of Exeter
Exeter, Devon, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter
Investigators
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Principal Investigator: Marlou Dirks, PhD University of Exeter
More Information
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03934632    
Other Study ID Numbers: 180509/B/01
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No