Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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.
Information provided by (Responsible Party):
Humberto Nicastro, University of Sao Paulo Identifier:
First received: December 19, 2011
Last updated: February 22, 2013
Last verified: February 2013
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

Condition Intervention
Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght
Dietary Supplement: Leucine
Dietary Supplement: Alanine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leucine Dietary Supplement: Leucine
7,2 g/day during 3 months
Placebo Comparator: Alanine Dietary Supplement: Alanine
7,2 g/day during 3 months


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Vegetarians
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01496768

University of São Paulo - School of Physical Education and Sports
Sao Paulo, SP, Brazil, 05508030
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Kerolyn de Souza Valente University of Sao Paulo
  More Information

Responsible Party: Humberto Nicastro, PhD Student, University of Sao Paulo Identifier: NCT01496768     History of Changes
Other Study ID Numbers: 20120412 
Study First Received: December 19, 2011
Last Updated: February 22, 2013
Health Authority: Brazil: Ethics Committee processed this record on December 02, 2016