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

Sponsor

University of Exeter (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03934632

Collaborator

(none)

Enrollment

Location

Arms

43.6

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 15, 2019

Actual Primary Completion Date :

Mar 17, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Muscle protein breakdown rate [1 hour]
Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion

Secondary Outcome Measures

Muscle protein breakdown rate [3 hours]
Muscle protein breakdown rate (FBR, measured in %/h) during 3 hours of saline or amino acid infusion
Muscle protein synthesis rate [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

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Exeter	Exeter	Devon	United Kingdom	EX1 2LU

Sponsors and Collaborators

University of Exeter

Investigators

Principal Investigator: Marlou Dirks, PhD, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Exeter

ClinicalTrials.gov Identifier:

NCT03934632

Other Study ID Numbers:

180509/B/01

First Posted:

May 2, 2019

Last Update Posted:

Jan 6, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 6, 2022