Sports Nutritional Physiological PhenomenaNCT03655041
24-Wk β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
A study testing Beta-alanine in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo.
Trial summary
Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory… 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
- Sports Nutritional Physiological Phenomena
- What is being tested?
- Beta-alanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 15 Dec 2017
- 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
- Healthy males
Who cannot join
- Smokers
- Chronic disease
- Prior or current use of steroids
- Use of creatine in the last 6 months
- Use of beta-alanine in the last 6 months
About this study
Official title: 24-Weeks of β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.
- Being tested
- Beta-alanine, Placebo
- Keywords
- Physiological Phenomena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanineDietary supplement
Beta-alanine in sustained-release tablets to increase muscle carnosine content
PlaceboDietary supplement
Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine
| Study group | Role | What they receive |
|---|---|---|
| Beta-Alanine | Experimental | 6.4 g/day of beta-alanine for 24 weeks Receives: Dietary Supplement: Beta-alanine |
| Placebo | Placebo comparator | 6.4 g/day of maltodextrin for 24 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle taurine content in mmol/kg
Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies
Measured: Up to 24 weeks
Secondary outcomes (2)
Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L
Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase will be analysed from venous blood samples
Measured: Up to 24 weeks
Albumin; globulin; creatinine in mg/dL
Albumin; globulin; creatinine will be analysed from venous blood samples
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Feb 2013
- Primary completion15 Dec 2015
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Nutritional Physiological PhenomenaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 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
- Investigators
- Bruno Gualano, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655041
- Sponsor's protocol ID
- 24WKBA
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-Weeks of β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
- ClinicalTrials.gov ID
- NCT03655041
- Acronym / sponsor ID
- 24WKBA
- Keywords
- Physiological Phenomena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-Alanine | Experimental | Dietary Supplement: Beta-alanine6.4 g/day of beta-alanine for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo6.4 g/day of maltodextrin for 24 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males
Key exclusion criteria (5 listed)
- Smokers
- Chronic disease
- Prior or current use of steroids
- Use of creatine in the last 6 months
- Use of beta-alanine in the last 6 months
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 |
|---|---|---|
| Beta-alanineBeta-alanine in sustained-release tablets to increase muscle carnosine content | Dietary supplement | Beta-Alanine |
| PlaceboMaltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine | Dietary supplement | Placebo |
Primary outcome
Muscle taurine content in mmol/kg
Time frame: Up to 24 weeks
Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies
2 secondary outcomes
Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L
Time frame: Up to 24 weeks
Albumin; globulin; creatinine in mg/dL
Time frame: Up to 24 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 31 Aug 2018.
- Individual participant dataSharing planned: No
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.
Bruno Gualano, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Beta-alanine in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo.
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 1 inclusion and 5 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 taurine content in mmol/kg (time frame: Up to 24 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 31 Aug 2018.