- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305018
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation
May 4, 2011 updated by: University of Sao Paulo
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
This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 05508-030
- University of São Paulo - School of Physical Education and Sports
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Sedentary;
- No muscle disorders;
- Must be able to swallow tablets
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise and BCAA
|
7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days
|
|
EXPERIMENTAL: Exercise and Leucine
|
7 g of leucine + 7 g of alanine per day during 9 days
|
|
PLACEBO_COMPARATOR: Exercise and Placebo
|
14 g of alanine per day during 9 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle maximal strength
Time Frame: 4 days
|
4 days
|
|
Muscle edema
Time Frame: 4 days
|
4 days
|
|
Muscle soreness
Time Frame: 4 days
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle inflammation
Time Frame: 4 days
|
Immunohistochemistry, protein expression.
|
4 days
|
|
Muscle damage
Time Frame: 4 days
|
Serum creatine kinase
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ANTICIPATED)
January 1, 2012
Study Completion (ANTICIPATED)
August 1, 2012
Study Registration Dates
First Submitted
February 25, 2011
First Submitted That Met QC Criteria
February 25, 2011
First Posted (ESTIMATE)
February 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 5, 2011
Last Update Submitted That Met QC Criteria
May 4, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 071287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.