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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:
ClinicalTrials.gov Identifier:
NCT01496768
First Posted: December 21, 2011
Last Update Posted: February 25, 2013
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.
Information provided by (Responsible Party):
Humberto Nicastro, University of Sao Paulo
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Humberto Nicastro, University of Sao Paulo:

Primary Outcome Measures:
  • Muscle strenght [ Time Frame: 3 months ]
  • Body composition [ Time Frame: 3 months ]
  • Muscle cross-sectional area [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Glucose homeostasis [ Time Frame: 3 months ]
  • Lipid profile [ Time Frame: 3 months ]
  • Systemic inflammation [ Time Frame: 3 months ]

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

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT01496768


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

Responsible Party: Humberto Nicastro, PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01496768     History of Changes
Other Study ID Numbers: 20120412
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: February 25, 2013
Last Verified: February 2013