Healthy VolunteersNCT02744443
Leucine Supplementation in Young Subjects Undergoing Resistance Training
A study testing Leucine in people with Healthy Volunteers, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Apr 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- training experience > 12 months
- no previous use of anabolic steroids
- no diagnosed diseases or injuries at the time of recruitment
- one-maximum repetition strength (1-RM) in leg press ≥ 3.5 and ≤ 5.0 times the body weight
Who cannot join
- use of creatine or beta-alanine supplements for the last 3 months
- use of protein or aminoacids supplements for the last 1 month
- engagement in specific dietary restrictions
- engagement in competitive sports
Trial locations and contacts
1 site in 1 country.
About this study
Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training.
- Conditions
- Healthy Volunteers
- Being tested
- Leucine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Leucine | Experimental | Leucine supplementation (10 g/d) Receives: Dietary Supplement: Leucine |
| Placebo | Placebo comparator | Placebo supplementation (alanine, 10 g/d) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle cross-sectional area
B-mode ultrasound
Measured: 12 weeks
Secondary outcomes (1)
muscle strength
One repetition maximum (1RM) on 45º leg press machine and Muscular Endurance Test on 45º leg press machine
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744443
- Sponsor's protocol ID
- LeucineUSP
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucine Supplementation in Young Subjects Undergoing Resistance Training
- ClinicalTrials.gov ID
- NCT02744443
- Acronym / sponsor ID
- LeucineUSP
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Apr 2016 (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.
Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucine | Experimental | Dietary Supplement: LeucineLeucine supplementation (10 g/d) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation (alanine, 10 g/d) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- training experience > 12 months
- no previous use of anabolic steroids
- no diagnosed diseases or injuries at the time of recruitment
- one-maximum repetition strength (1-RM) in leg press ≥ 3.5 and ≤ 5.0 times the body weight
Key exclusion criteria (4 listed)
- use of creatine or beta-alanine supplements for the last 3 months
- use of protein or aminoacids supplements for the last 1 month
- engagement in specific dietary restrictions
- engagement in competitive sports
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 | Dietary supplement | Leucine |
| Placebo | Dietary supplement | Placebo |
Primary outcome
muscle cross-sectional area
Time frame: 12 weeks
B-mode ultrasound
1 secondary outcome
muscle strength
Time frame: 12 weeks
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 20 Apr 2016.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 Leucine in people with Healthy Volunteers, 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 4 inclusion and 4 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 20 Apr 2016. 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?
muscle cross-sectional area (time frame: 12 weeks). 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 20 Apr 2016.