NCT01496768

Brief 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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

December 19, 2011

Last Update Submit

February 22, 2013

Conditions

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

Outcome Measures

Primary Outcomes (3)

  • Muscle strenght

    3 months

  • Body composition

    3 months

  • Muscle cross-sectional area

    3 months

Secondary Outcomes (3)

  • Glucose homeostasis

    3 months

  • Lipid profile

    3 months

  • Systemic inflammation

    3 months

Study Arms (2)

Leucine

EXPERIMENTAL
Dietary Supplement: Leucine

Alanine

PLACEBO COMPARATOR
Dietary Supplement: Alanine

Interventions

LeucineDIETARY_SUPPLEMENT

7,2 g/day during 3 months

Leucine
AlanineDIETARY_SUPPLEMENT

7,2 g/day during 3 months

Alanine

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Vegetarians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo - School of Physical Education and Sports

São Paulo, São Paulo, 05508030, Brazil

Location

MeSH Terms

Interventions

LeucineAlanine

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Kerolyn de Souza Valente

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

BR(1)