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Completed

NCT Number: NCT03934632

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postabsorptive

Other

Saline will be infused to mimic postabsorptive circulating amino acid concentrations

Postprandial

Other

An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations

Immobilisation

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
May 2, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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