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Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation

Primary Purpose

Muscle Damage, Inflammation

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
BCAA
Leucine
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Damage focused on measuring Branched-chain amino acids, Leucine, Muscle damage, Inflammation, supplementation, resistance exercise-induced

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of São Paulo - School of Physical Education and Sports

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Exercise and BCAA

Exercise and Leucine

Exercise and Placebo

Arm Description

Outcomes

Primary Outcome Measures

Muscle maximal strength
Muscle edema
Muscle soreness

Secondary Outcome Measures

Muscle inflammation
Immunohistochemistry, protein expression.
Muscle damage
Serum creatine kinase

Full Information

First Posted
February 25, 2011
Last Updated
May 4, 2011
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01305018
Brief Title
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation
Official Title
Effects of Leucine and Branched-chain Amino Acids (BCAA) Supplementation on Resistance Exercise-induced Muscle Damage and Inflammation: a Randomized, Double-blind, and Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Suspended
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Inflammation
Keywords
Branched-chain amino acids, Leucine, Muscle damage, Inflammation, supplementation, resistance exercise-induced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and BCAA
Arm Type
Experimental
Arm Title
Exercise and Leucine
Arm Type
Experimental
Arm Title
Exercise and Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
BCAA
Intervention Description
7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine
Intervention Description
7 g of leucine + 7 g of alanine per day during 9 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
14 g of alanine per day during 9 days
Primary Outcome Measure Information:
Title
Muscle maximal strength
Time Frame
4 days
Title
Muscle edema
Time Frame
4 days
Title
Muscle soreness
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Muscle inflammation
Description
Immunohistochemistry, protein expression.
Time Frame
4 days
Title
Muscle damage
Description
Serum creatine kinase
Time Frame
4 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sedentary; No muscle disorders; Must be able to swallow tablets
Facility Information:
Facility Name
University of São Paulo - School of Physical Education and Sports
City
São Paulo
ZIP/Postal Code
05508-030
Country
Brazil

12. IPD Sharing Statement

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Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation

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