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
  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:


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 April 17, 2014