Muscle DamageNCT01305018
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation
A study testing BCAA and Leucine in people with Muscle Damage and Inflammation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Inflammation
- What is being tested?
- BCAA and Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary;
- No muscle disorders;
- Must be able to swallow tablets
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - School of Physical Education and Sports
São Paulo, São Paulo, 05508-030
About this study
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
This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.
- Conditions
- Muscle Damage, Inflammation
- Being tested
- BCAA, Leucine, Placebo
- Keywords
- Branched-chain amino acids, Leucine, Muscle damage, Inflammation, supplementation, resistance exercise-induced
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary supplement
7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days
LeucineDietary supplement
7 g of leucine + 7 g of alanine per day during 9 days
PlaceboDietary supplement
14 g of alanine per day during 9 days
| Study group | Role | What they receive |
|---|---|---|
| Exercise and BCAA | Experimental | Not described Receives: Dietary Supplement: BCAA |
| Exercise and Leucine | Experimental | Not described Receives: Dietary Supplement: Leucine |
| Exercise and Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle maximal strength
Measured: 4 days
Muscle edema
Measured: 4 days
Muscle soreness
Measured: 4 days
Secondary outcomes (2)
Muscle inflammation
Immunohistochemistry, protein expression.
Measured: 4 days
Muscle damage
Serum creatine kinase
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305018
- Sponsor's protocol ID
- 071287
- Status last verified
- Apr 2011
- First submitted
- 25 Feb 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01305018
- Acronym / sponsor ID
- 071287
- Conditions
- Muscle Damage, Inflammation
- Keywords
- Branched-chain amino acids, Leucine, Muscle damage, Inflammation, supplementation, resistance exercise-induced
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise and BCAA | Experimental | Dietary Supplement: BCAA |
| Exercise and Leucine | Experimental | Dietary Supplement: Leucine |
| Exercise and Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary;
- No muscle disorders;
- Must be able to swallow tablets
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAA7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days | Dietary supplement | Exercise and BCAA |
| Leucine7 g of leucine + 7 g of alanine per day during 9 days | Dietary supplement | Exercise and Leucine |
| Placebo14 g of alanine per day during 9 days | Dietary supplement | Exercise and Placebo |
Primary outcome
Muscle maximal strength
Time frame: 4 days
Muscle edema
Time frame: 4 days
Muscle soreness
Time frame: 4 days
2 secondary outcomes
Muscle inflammation
Time frame: 4 days
Muscle damage
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA and Leucine in people with Muscle Damage and Inflammation, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle maximal strength (time frame: 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.