NCT01305018

Brief Summary

This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

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

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 5, 2011

Status Verified

April 1, 2011

Enrollment Period

5 months

First QC Date

February 25, 2011

Last Update Submit

May 4, 2011

Conditions

Muscle DamageInflammation

Keywords

Branched-chain amino acidsLeucineMuscle damageInflammationsupplementationresistance exercise-induced

Outcome Measures

Primary Outcomes (3)

  • Muscle maximal strength

    4 days

  • Muscle edema

    4 days

  • Muscle soreness

    4 days

Secondary Outcomes (2)

  • Muscle inflammation

    4 days

  • Muscle damage

    4 days

Study Arms (3)

Exercise and BCAA

EXPERIMENTAL
Dietary Supplement: BCAA

Exercise and Leucine

EXPERIMENTAL
Dietary Supplement: Leucine

Exercise and Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

BCAADIETARY_SUPPLEMENT

7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days

Exercise and BCAA
LeucineDIETARY_SUPPLEMENT

7 g of leucine + 7 g of alanine per day during 9 days

Exercise and Leucine
PlaceboDIETARY_SUPPLEMENT

14 g of alanine per day during 9 days

Exercise and Placebo

Eligibility Criteria

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

You may qualify if:

  • Sedentary;
  • No muscle disorders;
  • Must be able to swallow tablets

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

MeSH Terms

Conditions

Inflammation

Interventions

Leucine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

August 1, 2012

Last Updated

May 5, 2011

Record last verified: 2011-04

Locations

BR(1)