Back to resultsLeucine Supplementation and Skeletal Muscle Disuse
Primary Purpose
Disuse Atrophy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Leucine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Disuse Atrophy focused on measuring Leucine, Skeletal Muscle Disuse, Atrophy, Proteolysis
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of anterior cruciate ligament injury
- Physically active
- Must be able to swallow tablets
- Non-smokers
- Do not use nutritional supplements
Exclusion Criteria:
- Post-surgical complications
Sites / Locations
- University of São Paulo - School of Physical Education and Sports
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Immobilization and Leucine
Immobilization and Placebo
Arm Description
Outcomes
Primary Outcome Measures
Skeletal muscle structure (cross-sectional area)
Secondary Outcome Measures
Molecular signalling pathways (hypertrophy, atrophy, and inflammation)
Full Information
NCT ID
NCT01192009
First Posted
August 30, 2010
Last Updated
February 22, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01192009
Brief Title
Leucine Supplementation and Skeletal Muscle Disuse
Official Title
Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Leucine supplementation is widely known for promoting strong influence on skeletal muscle remodeling. This study aims to evaluate the effect of leucine supplementation on disuse-induced skeletal muscle atrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Atrophy
Keywords
Leucine, Skeletal Muscle Disuse, Atrophy, Proteolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immobilization and Leucine
Arm Type
Experimental
Arm Title
Immobilization and Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine
Intervention Description
7.2 g of leucine during 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
7.2 g of alanine during 2 weeks
Primary Outcome Measure Information:
Title
Skeletal muscle structure (cross-sectional area)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Molecular signalling pathways (hypertrophy, atrophy, and inflammation)
Time Frame
2 weeks
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:
Clinical diagnosis of anterior cruciate ligament injury
Physically active
Must be able to swallow tablets
Non-smokers
Do not use nutritional supplements
Exclusion Criteria:
Post-surgical complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humberto Nicastro, PhD Student
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo - School of Physical Education and Sports
City
São Paulo
ZIP/Postal Code
05508-030
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18637185
Citation
Zanchi NE, Nicastro H, Lancha AH Jr. Potential antiproteolytic effects of L-leucine: observations of in vitro and in vivo studies. Nutr Metab (Lond). 2008 Jul 17;5:20. doi: 10.1186/1743-7075-5-20.
Results Reference
background
PubMed Identifier
20514547
Citation
Nicastro H, Artioli GG, Costa Ados S, Solis MY, da Luz CR, Blachier F, Lancha AH Jr. An overview of the therapeutic effects of leucine supplementation on skeletal muscle under atrophic conditions. Amino Acids. 2011 Feb;40(2):287-300. doi: 10.1007/s00726-010-0636-x. Epub 2010 Jun 1.
Results Reference
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Leucine Supplementation and Skeletal Muscle Disuse
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