NCT03797781

Brief Summary

The effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

January 7, 2019

Last Update Submit

September 25, 2020

Conditions

Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

  • Muscle size

    3 days

Secondary Outcomes (1)

  • Muscle strength

    3 days

Study Arms (3)

High protein

EXPERIMENTAL
Other: Lower limb immobilisation (leg brace) with varying levels of protein intake

Low protein

EXPERIMENTAL
Other: Lower limb immobilisation (leg brace) with varying levels of protein intake

Minimum protein

EXPERIMENTAL
Other: Lower limb immobilisation (leg brace) with varying levels of protein intake

Interventions

Lower limb immobilisation (leg brace) with varying levels of protein intakeOTHER

Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake

High proteinLow proteinMinimum protein

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>18 and \<28 no prescription medications or current illness.

You may not qualify if:

  • BMI \<18 and \>28 current prescription medication no history of leg injury.
  • Smoker
  • Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Health Science

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • Kilroe SP, Fulford J, Jackman S, Holwerda A, Gijsen A, van Loon L, Wall BT. Dietary protein intake does not modulate daily myofibrillar protein synthesis rates or loss of muscle mass and function during short-term immobilization in young men: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):548-561. doi: 10.1093/ajcn/nqaa136.

    PMID: 32469388DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

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

January 7, 2019

First Posted

January 9, 2019

Study Start

October 31, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

GB(1)