Leucine Supplementation and Skeletal Muscle Disuse

Disuse Atrophy Clinical Trial

Official title:

Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192009
• Other study ID #: 2009/02896-6
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: February 22, 2013
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disuse Atrophy

Intervention

Dietary Supplement:
• Leucine
7.2 g of leucine during 2 weeks
• Placebo
7.2 g of alanine during 2 weeks

Locations

Country	Name	City	State
Brazil	University of São Paulo - School of Physical Education and Sports	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle structure (cross-sectional area)		2 weeks	Yes
Secondary	Molecular signalling pathways (hypertrophy, atrophy, and inflammation)		2 weeks	Yes