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Leucine Supplementation and Skeletal Muscle Disuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01192009
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Disuse Atrophy Dietary Supplement: Leucine Dietary Supplement: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms
Study Start Date : April 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Skeletal muscle structure (cross-sectional area) [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Molecular signalling pathways (hypertrophy, atrophy, and inflammation) [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

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

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