HealthyNCT01350427
Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Signaling Pathways
A study testing Leucine supplementation, BCAA supplementation and Alanine supplementation in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. 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
- Healthy
- What is being tested?
- Leucine supplementation, BCAA supplementation and Alanine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Feb 2013
- 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
- Sedentaries
- Must be able to exercise
- Must be able to swallow tablets
Who cannot join
- Use of nutritional supplements
- Use of anti-inflammatory drugs
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, Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Remodelling Signaling Pathways: a Randomized, Double-blind, and Placebo-controlled Study
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.
- Conditions
- Healthy
- Being tested
- Leucine supplementation, BCAA supplementation, Alanine supplementation
- Keywords
- leucine supplementation, BCCA supplementation, resistance exercise-induced muscle remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine supplementationDietary supplement
1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine
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
Alanine supplementationDietary supplement
1 bout of resistance exercise and supplementation of 9.6 g of alanine
| Study group | Role | What they receive |
|---|---|---|
| Leucine | Experimental | Not described Receives: Dietary Supplement: Leucine supplementation |
| BCAA | Experimental | Not described Receives: Dietary Supplement: BCAA supplementation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Alanine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein synthesis
Phosphorylation of proteins involved in protein synthesis
Measured: 1 hour
Protein degradation
Expression of protein involved in proteolytic pathway
Measured: 1 hour
Inflammation
Expression of systemic and muscular cytokines
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humberto Nicastro, University of Sao Paulo
- Investigators
- Claudia R da Luz, Master Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350427
- Sponsor's protocol ID
- 2011/04690-6
- Status last verified
- Feb 2013
- First submitted
- 2 May 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Leucine, Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Remodelling Signaling Pathways: a Randomized, Double-blind, and Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01350427
- Acronym / sponsor ID
- 2011/04690-6
- Conditions
- Healthy
- Keywords
- leucine supplementation, BCCA supplementation, resistance exercise-induced muscle remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 May 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 leucine and branched-chain amino acids supplementation on skeletal muscle remodeling signaling pathways induced by resistance exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leucine | Experimental | Dietary Supplement: Leucine supplementation |
| BCAA | Experimental | Dietary Supplement: BCAA supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Alanine supplementation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentaries
- Must be able to exercise
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Use of nutritional supplements
- Use of anti-inflammatory drugs
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 |
|---|---|---|
| Leucine supplementation1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine | Dietary supplement | Leucine |
| BCAA supplementation1 bout of resistance exercise and supplementation of 4.0 g of leucine + 2.8 g of isoleucine + 2.8 g of valine | Dietary supplement | BCAA |
| Alanine supplementation1 bout of resistance exercise and supplementation of 9.6 g of alanine | Dietary supplement | Placebo |
Primary outcome
Protein synthesis
Time frame: 1 hour
Phosphorylation of proteins involved in protein synthesis
Protein degradation
Time frame: 1 hour
Expression of protein involved in proteolytic pathway
Inflammation
Time frame: 1 hour
Expression of systemic and muscular cytokines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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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.
Claudia R da Luz, Master Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine supplementation, BCAA supplementation and Alanine supplementation in people with Healthy, 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 2 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: finished, as of the sponsor's last update on 25 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Protein synthesis (time frame: 1 hour). 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 25 Feb 2013.