search
Back to results

Protein Ingestion and Skeletal Muscle Atrophy

Primary Purpose

Muscle Atrophy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lower limb immobilisation (leg brace) with varying levels of protein intake
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Atrophy

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sport and Health Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High protein

Low protein

Minimum protein

Arm Description

Outcomes

Primary Outcome Measures

Muscle size

Secondary Outcome Measures

Muscle strength

Full Information

First Posted
January 7, 2019
Last Updated
September 25, 2020
Sponsor
University of Exeter
search

1. Study Identification

Unique Protocol Identification Number
NCT03797781
Brief Title
Protein Ingestion and Skeletal Muscle Atrophy
Official Title
Understanding the Role of Protein Ingestion on Skeletal Muscle Atrophy During an Acute Period of Disuse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High protein
Arm Type
Experimental
Arm Title
Low protein
Arm Type
Experimental
Arm Title
Minimum protein
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lower limb immobilisation (leg brace) with varying levels of protein intake
Intervention Description
Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
Primary Outcome Measure Information:
Title
Muscle size
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Muscle strength
Time Frame
3 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI >18 and <28 no prescription medications or current illness. Exclusion Criteria: 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.
Facility Information:
Facility Name
Sport and Health Science
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32469388
Citation
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.
Results Reference
derived

Learn more about this trial

Protein Ingestion and Skeletal Muscle Atrophy

We'll reach out to this number within 24 hrs