Leucine Supplementation and Skeletal Muscle Disuse
Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 25, 2013
February 1, 2013
1.8 years
August 30, 2010
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Skeletal muscle structure (cross-sectional area)
2 weeks
Secondary Outcomes (1)
Molecular signalling pathways (hypertrophy, atrophy, and inflammation)
2 weeks
Study Arms (2)
Immobilization and Leucine
EXPERIMENTALImmobilization and Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of anterior cruciate ligament injury
- Physically active
- Must be able to swallow tablets
- Non-smokers
- Do not use nutritional supplements
You may not qualify if:
- Post-surgical complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of São Paulo - School of Physical Education and Sports
São Paulo, São Paulo, 05508-030, Brazil
Related Publications (2)
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.
PMID: 18637185BACKGROUNDNicastro 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.
PMID: 20514547BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Humberto Nicastro, PhD Student
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 30, 2010
First Posted
August 31, 2010
Study Start
April 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 25, 2013
Record last verified: 2013-02