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

Study Overview

• Status: Suspended
• Conditions: Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght
• Intervention / Treatment: Dietary supplement: Leucine; Dietary supplement: Alanine

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05508030
      • University of São Paulo - School of Physical Education and Sports

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Vegetarians

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body composition	3 months
Muscle strenght	3 months
Muscle cross-sectional area	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Lipid profile	3 months
Glucose homeostasis	3 months
Systemic inflammation	3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Kerolyn de Souza Valente, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 20120412