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Leucine Supplementation and Skeletal Muscle Disuse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Humberto Nicastro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01192009
First received: August 30, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Disuse Atrophy
 Dietary Supplement: Leucine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms

Resource links provided by NLM:

Drug Information available for: Leucine
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Skeletal muscle structure (cross-sectional area) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Molecular signalling pathways (hypertrophy, atrophy, and inflammation) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: April 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immobilization and Leucine Dietary Supplement: Leucine
7.2 g of leucine during 2 weeks
Placebo Comparator: Immobilization and Placebo Dietary Supplement: Placebo
7.2 g of alanine during 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192009

Locations
Brazil
University of São Paulo - School of Physical Education and Sports
São Paulo, Brazil, 05508-030
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Humberto Nicastro, PhD Student University of São Paulo
  More Information

Publications:

Responsible Party: Humberto Nicastro, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01192009     History of Changes
Other Study ID Numbers: 2009/02896-6
Study First Received: August 30, 2010
Last Updated: February 22, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Leucine
Skeletal Muscle Disuse
Atrophy
Proteolysis

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Atrophy
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013