NCT01350427

Brief Summary

This study aims to evaluate the effects of leucine and branched-chain amino acids supplementation on skeletal muscle remodeling signaling pathways induced by resistance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

May 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.5 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

1.5 years

First QC Date

May 2, 2011

Last Update Submit

February 22, 2013

Conditions

Healthy

Keywords

leucine supplementationBCCA supplementationresistance exercise-induced muscle remodeling

Outcome Measures

Primary Outcomes (3)

  • Protein synthesis

    Phosphorylation of proteins involved in protein synthesis

    1 hour

  • Protein degradation

    Expression of protein involved in proteolytic pathway

    1 hour

  • Inflammation

    Expression of systemic and muscular cytokines

    1 hour

Study Arms (3)

Leucine

EXPERIMENTAL
Dietary Supplement: Leucine supplementation

BCAA

EXPERIMENTAL
Dietary Supplement: BCAA supplementation

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Alanine supplementation

Interventions

Leucine supplementationDIETARY_SUPPLEMENT

1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine

Leucine
BCAA supplementationDIETARY_SUPPLEMENT

1 bout of resistance exercise and supplementation of 4.0 g of leucine + 2.8 g of isoleucine + 2.8 g of valine

BCAA
Alanine supplementationDIETARY_SUPPLEMENT

1 bout of resistance exercise and supplementation of 9.6 g of alanine

Placebo

Eligibility Criteria

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

You may qualify if:

  • Sedentaries
  • Must be able to exercise
  • Must be able to swallow tablets

You may not qualify if:

  • Use of nutritional supplements
  • Use of anti-inflammatory drugs

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, 05508-030, Brazil

Location

Study Officials

  • Claudia R da Luz, Master Student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 9, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

BR(1)