Beta-alanineNCT05096793
Acute Supplementation With Beta-Alanine Improves Performance in Aerobic-anaerobic Transition Zones in Endurance Athletes
A study testing beta alanine in people with Beta-alanine, run by University of Americas - Chili at 1 site in Chile.
Trial summary
The use of beta-alanine (BA) to increase physical performance is widely documented. However, the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone is still uncertain. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Beta-alanine
- What is being tested?
- beta alanine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 3 May 2021to 31 Aug 2021
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criterion was years of training for endurance events (participants had a minimum of two years running middle-distance and long-distance events).
Who cannot join
- The exclusion criterion was the inability to perform the 6-minute run test
Trial locations and contacts
1 site in 1 country.
About this study
The use of beta-alanine (BA) to increase physical performance is widely documented. However, the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone is still uncertain. The objective of this study was to determine the acute effect of low and high-dose BA trials on maximal aerobic speed (MAS) in endurance athletes. We hypothesized that high doses of BA have a greater effect than low doses, both compared to baseline. Twelve male endurance athletes volunteered for the study. The experimental design applied was randomized cross-over, double-blind. Treatment included three 6-minute run tests (6-MRT), the first as a baseline, then randomized 6-MRT with low (30 mg·kg-1) and high (45 mg·kg-1) dose BA trials. The 6-MRTs were separated by 72 hours. The main variable of the study was the distance (m) performed in the 6-MRT. Differences between tests were established through ANOVA and Tukey's multiple comparison tests (p < 0.05).
Read the detailed description
In this original research, we determined the acute effect of low (30 mg·kg-1) and high-dose (45 mg·kg-1) BA trials on maximal aerobic speed (MAS) in endurance athletes. At the same time, we compared the effect size with of BA.
- Conditions
- Beta-alanine
- Being tested
- beta alanine
- Keywords
- beta-alanine, ergogenic aid, physical performance, aerobic-anaerobic transition zones, maximal aerobic speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta alanineDietary supplement
On day 1, all participants completed the 6-MRT corresponding to baseline. Then, on days 2 and 3, each participant performed the 6-MRT with 30 mg·kg-1 and 45 mg·kg-1 of BA (low and high-dose trials, respectively). BA was purchased in powder format from a factory specializing in sports supplements. BA was colorless when diluted in water and had a characteristic taste. This format of BA (powder) allowed personalized dosing for each participant. The research team performed the personalized dosing before the application of the treatment. Between the evaluation days, there was 72 hours difference. The 30 mg·kg-1 or 45 mg·kg-1 BA administration was done with a double-blind method. Thus, on day 2, 50% of the sample performed the 6-MRT supplemented with 30 mg·kg-1 BA, while the other 50% performed the 6-MRT with 45 mg·kg-1 BA. On day 3, those participants who completed the 6-MRT with 30 mg·kg-1 BA now performed with 45 mg·kg-1 BA and vice versa.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | the distance in the 6-MRT compared to baseline Receives: Dietary Supplement: beta alanine |
| Low doses | Experimental | the distance in the 6-MRT compared to baseline Receives: Dietary Supplement: beta alanine |
| High doses | Experimental | the distance in the 6-MRT compared to baseline Receives: Dietary Supplement: beta alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute race test (meters)
The test was performed on an official 400 m athletic track simultaneously every measurement day (09:00 - 11:00 a.m.) and under similar climatic conditions (temperature = 16 - 18° C and relative humidity = 70 - 80%). Also, to simulate the reality of the competition, the 6-MRT was performed in subgroups of three participants. These subgroups were maintained throughout the intervention, modifying only the dose of BA ingested.
Measured: at the end of the 6 minute test
Secondary outcomes (2)
Lactate
A lactometer (h/p/cosmos®) was used to measure capillary [La]. This lactometer generates an enzymatic-amperometric detection of lactate with an accuracy of ± 3% (minimum standard deviation of 0.2 mmol·L-1), sample volume 0.2 μL, and with a measurement range of 0.5-25.0 mmol·L-1.
Measured: at the end of the 6 minute test
Heart Rate
A heart rate monitor (Polar H10®) was used to measure HR, while the data was stored using the Polar Beat® application.
Measured: at the end of the 6 minute test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start3 May 2021
- Primary completion9 May 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Beta-alanineStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- The experimental design applied was randomized cross-over and double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Huerta Ojeda, University of Americas - Chili
- Investigators
- Hernán Cañon, Ph.D., Study director, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096793
- Sponsor's protocol ID
- 04102021
- Other IDs
- 04102021
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trexler ET, Smith-Ryan AE, Stout JR, Hoffman JR, Wilborn CD, Sale C, Kreider RB, Jager R, Earnest CP, Bannock L, Campbell B, Kalman D, Ziegenfuss TN, Antonio J. International society of sports nutrition position stand: Beta-Alanine. J Int Soc Sports Nutr. 2015 Jul 15;12:30. doi: 10.1186/s12970-015-0090-y. eCollection 2015.
PubMed 26175657Boldyrev AA, Aldini G, Derave W. Physiology and pathophysiology of carnosine. Physiol Rev. 2013 Oct;93(4):1803-45. doi: 10.1152/physrev.00039.2012.
PubMed 24137022Bex T, Chung W, Baguet A, Achten E, Derave W. Exercise training and Beta-alanine-induced muscle carnosine loading. Front Nutr. 2015 May 7;2:13. doi: 10.3389/fnut.2015.00013. eCollection 2015.
PubMed 25988141Peeling P, Binnie MJ, Goods PSR, Sim M, Burke LM. Evidence-Based Supplements for the Enhancement of Athletic Performance. Int J Sport Nutr Exerc Metab. 2018 Mar 1;28(2):178-187. doi: 10.1123/ijsnem.2017-0343. Epub 2018 Feb 21.
PubMed 29465269Santesteban Moriones V, Ibanez Santos J. [Ergogenic aids in sport]. Nutr Hosp. 2017 Feb 1;34(1):204-215. doi: 10.20960/nh.997. Spanish.
PubMed 28244793Mate-Munoz JL, Lougedo JH, Garnacho-Castano MV, Veiga-Herreros P, Lozano-Estevan MDC, Garcia-Fernandez P, de Jesus F, Guodemar-Perez J, San Juan AF, Dominguez R. Effects of beta-alanine supplementation during a 5-week strength training program: a randomized, controlled study. J Int Soc Sports Nutr. 2018 Apr 25;15:19. doi: 10.1186/s12970-018-0224-0. eCollection 2018.
PubMed 29713250Bassinello D, de Salles Painelli V, Dolan E, Lixandrao M, Cajueiro M, de Capitani M, Saunders B, Sale C, Artioli GG, Gualano B, Roschel H. Beta-alanine supplementation improves isometric, but not isotonic or isokinetic strength endurance in recreationally strength-trained young men. Amino Acids. 2019 Jan;51(1):27-37. doi: 10.1007/s00726-018-2593-8. Epub 2018 Jun 15.
PubMed 29905904Furst T, Massaro A, Miller C, Williams BT, LaMacchia ZM, Horvath PJ. beta-Alanine supplementation increased physical performance and improved executive function following endurance exercise in middle aged individuals. J Int Soc Sports Nutr. 2018 Jul 11;15(1):32. doi: 10.1186/s12970-018-0238-7.
PubMed 29996843Santana JO, de Freitas MC, Dos Santos DM, Rossi FE, Lira FS, Rosa-Neto JC, Caperuto EC. Beta-Alanine Supplementation Improved 10-km Running Time Trial in Physically Active Adults. Front Physiol. 2018 Aug 8;9:1105. doi: 10.3389/fphys.2018.01105. eCollection 2018.
PubMed 30135662Huerta-Ojeda A, Contreras-Montilla O, Galdames-Maliqueo S, Jorquera-Aguilera C, Fuentes-Kloss R, Guisado-Barrilao R. [Effects of acute supplementation with beta-alanine on a limited time test at maximum aerobic speed on endurance athletes]. Nutr Hosp. 2019 Jul 1;36(3):698-705. doi: 10.20960/nh.02310. Spanish.
PubMed 31144977Kindermann W, Simon G, Keul J. The significance of the aerobic-anaerobic transition for the determination of work load intensities during endurance training. Eur J Appl Physiol Occup Physiol. 1979 Sep;42(1):25-34. doi: 10.1007/BF00421101.
PubMed 499194Huerta Ojeda A, Tapia Cerda C, Poblete Salvatierra MF, Barahona-Fuentes G, Jorquera Aguilera C. Effects of Beta-Alanine Supplementation on Physical Performance in Aerobic-Anaerobic Transition Zones: A Systematic Review and Meta-Analysis. Nutrients. 2020 Aug 19;12(9):2490. doi: 10.3390/nu12092490.
PubMed 32824885Poole DC, Jones AM. Measurement of the maximum oxygen uptake V̇o2max: V̇o2peak is no longer acceptable. J Appl Physiol (1985). 2017 Apr 1;122(4):997-1002. doi: 10.1152/japplphysiol.01063.2016. Epub 2017 Feb 2.
PubMed 28153947Billat LV, Koralsztein JP. Significance of the velocity at VO2max and time to exhaustion at this velocity. Sports Med. 1996 Aug;22(2):90-108. doi: 10.2165/00007256-199622020-00004.
PubMed 8857705Faude O, Kindermann W, Meyer T. Lactate threshold concepts: how valid are they? Sports Med. 2009;39(6):469-90. doi: 10.2165/00007256-200939060-00003.
PubMed 19453206
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Supplementation With Beta-Alanine Improves Performance in Aerobic-anaerobic Transition Zones in Endurance Athletes
- ClinicalTrials.gov ID
- NCT05096793
- Acronym / sponsor ID
- 04102021
- Conditions
- Beta-alanine
- Keywords
- beta-alanine, ergogenic aid, physical performance, aerobic-anaerobic transition zones, maximal aerobic speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Oct 2021 (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.
The use of beta-alanine (BA) to increase physical performance is widely documented. However, the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone is still uncertain. The objective of this study was to determine the acute effect of low and high-dose BA trials on maximal aerobic speed (MAS) in endurance athletes. We hypothesized that high doses of BA have a greater effect than low doses, both compared to baseline. Twelve male endurance athletes volunteered for the study. The experimental design applied was randomized cross-over, double-blind. Treatment included three 6-minute run tests (6-MRT), the first as a baseline, then randomized 6-MRT with low (30 mg·kg-1) and high (45 mg·kg-1) dose BA trials. The 6-MRTs were separated by 72 hours. The main variable of the study was the distance (m) performed in the 6-MRT. Differences between tests were established through ANOVA and Tukey's multiple comparison tests (p < 0.05).
Detailed description
In this original research, we determined the acute effect of low (30 mg·kg-1) and high-dose (45 mg·kg-1) BA trials on maximal aerobic speed (MAS) in endurance athletes. At the same time, we compared the effect size with of BA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The experimental design applied was randomized cross-over and double-blind
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: beta alaninethe distance in the 6-MRT compared to baseline |
| Low doses | Experimental | Dietary Supplement: beta alaninethe distance in the 6-MRT compared to baseline |
| High doses | Experimental | Dietary Supplement: beta alaninethe distance in the 6-MRT compared to baseline |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criterion was years of training for endurance events (participants had a minimum of two years running middle-distance and long-distance events).
Key exclusion criteria (1 listed)
- The exclusion criterion was the inability to perform the 6-minute run test
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 alanineOn day 1, all participants completed the 6-MRT corresponding to baseline. Then, on days 2 and 3, each participant performed the 6-MRT with 30 mg·kg-1 and 45 mg·kg-1 of BA (low and high-dose trials, respectively). BA was purchased in powder format from a factory specializing in sports supplements. BA was colorless when diluted in water and had a characteristic taste. This format of BA (powder) allowed personalized dosing for each participant. The research team performed the personalized dosing before the application of the treatment. Between the evaluation days, there was 72 hours difference. The 30 mg·kg-1 or 45 mg·kg-1 BA administration was done with a double-blind method. Thus, on day 2, 50% of the sample performed the 6-MRT supplemented with 30 mg·kg-1 BA, while the other 50% performed the 6-MRT with 45 mg·kg-1 BA. On day 3, those participants who completed the 6-MRT with 30 mg·kg-1 BA now performed with 45 mg·kg-1 BA and vice versa. | Dietary supplement | Control, High doses, Low doses |
Primary outcome
6-minute race test (meters)
Time frame: at the end of the 6 minute test
The test was performed on an official 400 m athletic track simultaneously every measurement day (09:00 - 11:00 a.m.) and under similar climatic conditions (temperature = 16 - 18° C and relative humidity = 70 - 80%). Also, to simulate the reality of the competition, the 6-MRT was performed in subgroups of three participants. These subgroups were maintained throughout the intervention, modifying only the dose of BA ingested.
2 secondary outcomes
Lactate
Time frame: at the end of the 6 minute test
Heart Rate
Time frame: at the end of the 6 minute test
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 3 Nov 2021.
- Results publication: PubMed 26175657Trexler ET, Smith-Ryan AE, Stout JR, Hoffman JR, Wilborn CD, Sale C, Kreider RB, Jager R, Earnest CP, Bannock L, Campbell B, Kalman D, Ziegenfuss TN, Antonio J. International society of sports nutrition position stand: Beta-Alanine. J Int Soc Sports Nutr. 2015 Jul 15;12:30. doi: 10.1186/s12970-015-0090-y. eCollection 2015.
- Results publication: PubMed 24137022Boldyrev AA, Aldini G, Derave W. Physiology and pathophysiology of carnosine. Physiol Rev. 2013 Oct;93(4):1803-45. doi: 10.1152/physrev.00039.2012.
- Results publication: PubMed 25988141Bex T, Chung W, Baguet A, Achten E, Derave W. Exercise training and Beta-alanine-induced muscle carnosine loading. Front Nutr. 2015 May 7;2:13. doi: 10.3389/fnut.2015.00013. eCollection 2015.
- Results publication: PubMed 29465269Peeling P, Binnie MJ, Goods PSR, Sim M, Burke LM. Evidence-Based Supplements for the Enhancement of Athletic Performance. Int J Sport Nutr Exerc Metab. 2018 Mar 1;28(2):178-187. doi: 10.1123/ijsnem.2017-0343. Epub 2018 Feb 21.
- Results publication: PubMed 28244793Santesteban Moriones V, Ibanez Santos J. [Ergogenic aids in sport]. Nutr Hosp. 2017 Feb 1;34(1):204-215. doi: 10.20960/nh.997. Spanish.
- Results publication: PubMed 29713250Mate-Munoz JL, Lougedo JH, Garnacho-Castano MV, Veiga-Herreros P, Lozano-Estevan MDC, Garcia-Fernandez P, de Jesus F, Guodemar-Perez J, San Juan AF, Dominguez R. Effects of beta-alanine supplementation during a 5-week strength training program: a randomized, controlled study. J Int Soc Sports Nutr. 2018 Apr 25;15:19. doi: 10.1186/s12970-018-0224-0. eCollection 2018.
- Results publication: PubMed 29905904Bassinello D, de Salles Painelli V, Dolan E, Lixandrao M, Cajueiro M, de Capitani M, Saunders B, Sale C, Artioli GG, Gualano B, Roschel H. Beta-alanine supplementation improves isometric, but not isotonic or isokinetic strength endurance in recreationally strength-trained young men. Amino Acids. 2019 Jan;51(1):27-37. doi: 10.1007/s00726-018-2593-8. Epub 2018 Jun 15.
- Results publication: PubMed 29996843Furst T, Massaro A, Miller C, Williams BT, LaMacchia ZM, Horvath PJ. beta-Alanine supplementation increased physical performance and improved executive function following endurance exercise in middle aged individuals. J Int Soc Sports Nutr. 2018 Jul 11;15(1):32. doi: 10.1186/s12970-018-0238-7.
- Results publication: PubMed 30135662Santana JO, de Freitas MC, Dos Santos DM, Rossi FE, Lira FS, Rosa-Neto JC, Caperuto EC. Beta-Alanine Supplementation Improved 10-km Running Time Trial in Physically Active Adults. Front Physiol. 2018 Aug 8;9:1105. doi: 10.3389/fphys.2018.01105. eCollection 2018.
- Results publication: PubMed 31144977Huerta-Ojeda A, Contreras-Montilla O, Galdames-Maliqueo S, Jorquera-Aguilera C, Fuentes-Kloss R, Guisado-Barrilao R. [Effects of acute supplementation with beta-alanine on a limited time test at maximum aerobic speed on endurance athletes]. Nutr Hosp. 2019 Jul 1;36(3):698-705. doi: 10.20960/nh.02310. Spanish.
- Results publication: PubMed 499194Kindermann W, Simon G, Keul J. The significance of the aerobic-anaerobic transition for the determination of work load intensities during endurance training. Eur J Appl Physiol Occup Physiol. 1979 Sep;42(1):25-34. doi: 10.1007/BF00421101.
- Results publication: PubMed 32824885Huerta Ojeda A, Tapia Cerda C, Poblete Salvatierra MF, Barahona-Fuentes G, Jorquera Aguilera C. Effects of Beta-Alanine Supplementation on Physical Performance in Aerobic-Anaerobic Transition Zones: A Systematic Review and Meta-Analysis. Nutrients. 2020 Aug 19;12(9):2490. doi: 10.3390/nu12092490.
- Individual participant dataSharing planned: No
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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.
Hernán Cañon, Ph.D. study director
University of Americas - Chili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta alanine in people with Beta-alanine, run by University of Americas - Chili at 1 site in Chile.
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 1 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 3 Nov 2021. 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 Chile. 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. 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?
6-minute race test (meters) (time frame: at the end of the 6 minute test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096793, which also lists 28 linked publications.
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 3 Nov 2021.