- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797781
Protein Ingestion and Skeletal Muscle Atrophy
September 25, 2020 updated by: University of Exeter
Understanding the Role of Protein Ingestion on Skeletal Muscle Atrophy During an Acute Period of Disuse
The effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- Sport and Health Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High protein
|
Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
|
Experimental: Low protein
|
Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
|
Experimental: Minimum protein
|
Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle size
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle strength
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
January 7, 2019
First Submitted That Met QC Criteria
January 7, 2019
First Posted (Actual)
January 9, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 25, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6500619582
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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