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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01496768
Other study ID # 20120412
Secondary ID
Status Suspended
Phase N/A
First received December 19, 2011
Last updated February 22, 2013
Start date January 2012
Est. completion date February 2013

Study information

Verified date February 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Suspended
Enrollment 24
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Non-smokers;

- Healthy;

- Non-users of dietary supplements and drugs

- Not engaged in any regular physical activity program

Exclusion Criteria:

- Vegetarians

Study Design

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


Related Conditions & MeSH terms

  • Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght

Intervention

Dietary Supplement:
Leucine
7,2 g/day during 3 months
Alanine
7,2 g/day during 3 months

Locations

Country Name City State
Brazil University of São Paulo - School of Physical Education and Sports Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strenght 3 months Yes
Primary Body composition 3 months Yes
Primary Muscle cross-sectional area 3 months Yes
Secondary Glucose homeostasis 3 months Yes
Secondary Lipid profile 3 months Yes
Secondary Systemic inflammation 3 months Yes