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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934632
• Other study ID #: 180509/B/01
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: January 9, 2023

Study information

• Verified date: March 2023
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 9, 2023
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Postabsorptive
Saline will be infused to mimic postabsorptive circulating amino acid concentrations
• 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

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein breakdown rate	Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion	1 hour
Secondary	Muscle protein breakdown rate	Muscle protein breakdown rate (FBR, measured in %/h) during 3 hours of saline or amino acid infusion	3 hours
Secondary	Muscle protein synthesis rate	Muscle protein synthesis rate (FSR, measured in %/h) during 3 hours of saline or amino acid infusion measured using a D5 phenylalanine infusion	3 hours