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Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Humberto Nicastro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01496768
First received: December 19, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes

December 19, 2011
February 22, 2013
January 2012
February 2013   (final data collection date for primary outcome measure)
  • Muscle strenght [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Muscle cross-sectional area [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01496768 on ClinicalTrials.gov Archive Site
  • Glucose homeostasis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Systemic inflammation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects: a Randomized, Double-blind, and Placebo Controlled Trial

This study aims to evaluate the effects of chronic leucine supplemetion on glucose homeostasis, body compositin, muscle mass and strength of healthy and young subjects
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght
  • Dietary Supplement: Leucine
    7,2 g/day during 3 months
  • Dietary Supplement: Alanine
    7,2 g/day during 3 months
  • Experimental: Leucine
    Intervention: Dietary Supplement: Leucine
  • Placebo Comparator: Alanine
    Intervention: Dietary Supplement: Alanine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
24
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-smokers;
  • Healthy;
  • Non-users of dietary supplements and drugs
  • Not engaged in any regular physical activity program

Exclusion Criteria:

  • Vegetarians
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01496768
20120412
Yes
Humberto Nicastro, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Kerolyn de Souza Valente University of Sao Paulo
University of Sao Paulo
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP