Exercise TrainingNCT04936737
The Influence of Exercise on Tissue Beta-alanine Uptake and Carnosine Synthesis Rates
A study testing Beta-alanine supplementation and High intensity interval exercise in people with Exercise Training and Carnosine, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
B-alanine supplementation is highly efficient in increasing intramuscular carnosine content, leading to improved physical performance, especially in high-intensity exercises (HIIE). 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
- Exercise Training, Carnosine, Dietary Supplements
- What is being tested?
- Beta-alanine supplementation and High intensity interval exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2021to 31 Dec 2023
- 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
- omnivorous diet for> 6 months
- practice physical activities for> 2 h · week-1
- stable body mass (variation <2 kg in the last 30 days)
Who cannot join
- use of food supplements in the last six months containing β-alanine
- diagnosis of chronic diseases or any other condition that prevents them from performing the proposed procedures
- smoking
- current or past use of anabolic steroids or other ergogenic drugs
- Use of medications that may affect the assessments in this study, including insulin, GH, and thyroid hormone
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, 05508-030
Bruno Gualano, Phd, 551130918783, gualano@usp.br
Bruno Gualano, Phd
About this study
B-alanine supplementation is highly efficient in increasing intramuscular carnosine content, leading to improved physical performance, especially in high-intensity exercises (HIIE). It seems that exercise per se can modulate carnosine content; however, it remains uncertain whether physical training or training status can influence B-alanine supplementation responses. Thus, this work aims to assess whether HIIE can increase B-alanine uptake by peripheral tissues and, more specifically, skeletal muscle and increase intramuscular carnosine synthesis. The volunteers will be evaluated in two conditions: intake of B-alanine + exercise (B-EX) and B-alanine intake only (B-Ala). This process will be divided into two blocks of six days (Thursday to Thursday - without the weekend) with a 4-6 weeks washout. In the B-EX block, a 20-minute HIIE session will be held. In the B-Ala block, the same procedures will be adopted for the B-EX block, with the replacement of the HIIE for 20 minutes of rest sitting on the cycle ergometer. We will evaluate the determination of muscle B-alanine, plasma, and urine, the gene expression of carnosine-related enzymes and transporters, the enzymes Carnosine Synthase 1 (CARNS1), carnosine dipeptidase 2 (CN2), taurine transporter (TauT), PAT1, and phosphorylated Na + / K + / ATPase. The hypotheses are: 1) acute physical exercise increases the uptake of B-alanine by the skeletal muscle; 2) this effect is mediated by the increased activity of the Na + / K + / ATPase pump; 3) this effect, when repeated over five training sessions, results in observable increases in β-alanine → carnosine conversion in skeletal muscle.
Read the detailed description
B-alanine is a non-essential, non-proteinogenic amino acid found in deficient skeletal muscle concentrations. This deficiency makes B-alanine a rate-limiting factor for carnosine synthesis. B-alanine supplementation is highly efficient in increasing intramuscular carnosine content, leading to improved physical performance, especially in high-intensity exercises (HIIE). It seems that exercise per se can modulate carnosine content; however, it remains uncertain whether physical training or training status can influence B-alanine supplementation responses. Thus, this work aims to assess whether HIIE can increase B-alanine uptake by peripheral tissues and, more specifically, skeletal muscle and increase intramuscular carnosine synthesis. A crossover counterbalanced study will be conducted. The volunteers will be evaluated in two conditions: intake of B-alanine + exercise (B-EX) and B-alanine intake only (B-Ala). The dosage will be 20 mg · kg-1 (powder diluted in water). This process will be divided into two blocks of six days (Thursday to Thursday - without the weekend) with a 4-6 weeks washout. In the B-EX block, a 20-minute HIIE session will be held. Next, B-alanine supplementation will be administered. Immediately after exercise, in a 150-minute rest, collections of venous blood samples will be performed, and the muscle biopsy and urine collection will be collected pre-test and post-test. In the next three days (Thursday to Wednesday), this same protocol will be repeated without blood, muscle, or urine collections. On these days, the B-alanine supplementation will be administrated before and after the protocol (B-EX and B-Ala), in the same dosage of 20mg.kg-1. On the 6th day (Thursday), the complete protocol will be carried out, including the collection of biological materials. In the B-Ala block, the same procedures will be adopted for the B-EX block, with the replacement of the HIIE for 20 minutes of rest sitting on the cycle ergometer. The nutritional parameters will be evaluated during the two blocks by dietary diaries in software (Dietbox) that includes images and the description of all the volunteer food in the day. It will be determined that during the blocks (B-EX and B-ala), the Beta-alanine intake by food is limited to 300mg per day. The analysis of the determination of muscle B-alanine, plasma, and urine, muscle carnosine will be performed by HPLC-ESI + -MS / MS. The gene expression of carnosine-related enzymes and transporters will be analyzed using the real-time PCR technique. The enzymes CARNS1, CN2, TauT, PAT1, and phosphorylated Na + / K + / ATPase will be analyzed using the Western Blot technique. Carnosine synthase activity will be carried out by incorporating [3H] B-alanine acid in the corresponding dipeptide. The analysis of paresthesia's presence and intensity will be through a scale adapted from LINGJÆRDE et al., 1987. The statistical analysis will be performed in the RStudio software and SAS software, using the mixed model to compare muscle, plasma, and urinary variables. Condition (B-Ex vs. B-ala) and time of collection (time) will be fixed factors, while the subjects will be random factors. Data sets containing values obtained at only 2 points in time (e.g., area below the plasma B-alanine curve) will be analyzed using Student's t-test for dependent samples if the data distribution is normal. If the data distribution is not normal, we will use the Wilcoxon sign test for pairs. The normality of data distribution will be assessed qualitatively using Q-Q Plot. Four different covariance matrix structures will be tested for each data set. The Schwarz-Bayesian criterion (lowest BIC value) will be used to select the matrix that best fits each data set. Hypothesis-guided contrast analysis of a single degree of freedom will test specific effects within and between conditions. The size of the Cohen effect (D) will be calculated for all variables. Significance will be accepted if p<0.05.
- Conditions
- Exercise Training, Carnosine, Dietary Supplements
- Being tested
- Beta-alanine supplementation, High intensity interval exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanine supplementationDietary supplement
The supplementation will be administrated in the dosage of 20mg.kg-1. On the first and the sixth (last one), one dose of beta-alanine will be taken. On the other four days of supplementation, the volunteers will take 2 doses (20mg.kg-1) of Beta-alanine.
High intensity interval exerciseOther
The HIIE sessions will consist of 10 series of 1 min of effort, divided into two blocks of 5 series each. There will be an interval of 5 min of passive recovery; within each block, the interval between sets will be 1 min of active recovery. The exercise will be conducted in a mechanical brake cycle ergometer, with load applied by placing washers on a load plate (Biotec 2100, Cefise, Brazil).
| Study group | Role | What they receive |
|---|---|---|
| Beta-alanine supplementation and high intensity exercise | Experimental | Individuals will participate in a high-intensity exercise and will be supplemented with beta-alanine. This protocol will be conducted for six non-consecutive days. Receives: Dietary Supplement: Beta-alanine supplementation; Other: High intensity interval exercise |
| Beta-alanine supplementation only | Experimental | In this protocol, the individuals will be supplemented with beta-alanine without the exercise protocol for six non-consecutive days. Receives: Dietary Supplement: Beta-alanine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Muscle Carnosine after B-alanina supplementation
HPLC-ESI+-MS/MS
Measured: This evaluation will be carried out with the muscle samples collected on the first and the sixth (last) day of the protocol.
Change from Baseline Plasma Beta-alanine after B-alanina supplementation
HPLC-ESI+-MS/MS
Measured: This evaluation will be carried out with the blood samples collected on the first and the sixth (last) day of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start6 May 2021
- Primary completion23 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Crossover
- Model description
- The order of treatments will be random
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
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
- Gabriella B Möller, Msc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936737
- Sponsor's protocol ID
- B-alanine and HIIT
- Status last verified
- Jun 2021
- First submitted
- 16 Apr 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Exercise on Tissue Beta-alanine Uptake and Carnosine Synthesis Rates
- ClinicalTrials.gov ID
- NCT04936737
- Acronym / sponsor ID
- B-alanine and HIIT
- Conditions
- Exercise Training, Carnosine, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jun 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.
B-alanine supplementation is highly efficient in increasing intramuscular carnosine content, leading to improved physical performance, especially in high-intensity exercises (HIIE). It seems that exercise per se can modulate carnosine content; however, it remains uncertain whether physical training or training status can influence B-alanine supplementation responses. Thus, this work aims to assess whether HIIE can increase B-alanine uptake by peripheral tissues and, more specifically, skeletal muscle and increase intramuscular carnosine synthesis. The volunteers will be evaluated in two conditions: intake of B-alanine + exercise (B-EX) and B-alanine intake only (B-Ala). This process will be divided into two blocks of six days (Thursday to Thursday - without the weekend) with a 4-6 weeks washout. In the B-EX block, a 20-minute HIIE session will be held. In the B-Ala block, the same procedures will be adopted for the B-EX block, with the replacement of the HIIE for 20 minutes of rest sitting on the cycle ergometer. We will evaluate the determination of muscle B-alanine, plasma, and urine, the gene expression of carnosine-related enzymes and transporters, the enzymes Carnosine Synthase 1 (CARNS1), carnosine dipeptidase 2 (CN2), taurine transporter (TauT), PAT1, and phosphorylated Na + / K + / ATPase. The hypotheses are: 1) acute physical exercise increases the uptake of B-alanine by the skeletal muscle; 2) this effect is mediated by the increased activity of the Na + / K + / ATPase pump; 3) this effect, when repeated over five training sessions, results in observable increases in β-alanine → carnosine conversion in skeletal muscle.
Detailed description
B-alanine is a non-essential, non-proteinogenic amino acid found in deficient skeletal muscle concentrations. This deficiency makes B-alanine a rate-limiting factor for carnosine synthesis. B-alanine supplementation is highly efficient in increasing intramuscular carnosine content, leading to improved physical performance, especially in high-intensity exercises (HIIE). It seems that exercise per se can modulate carnosine content; however, it remains uncertain whether physical training or training status can influence B-alanine supplementation responses. Thus, this work aims to assess whether HIIE can increase B-alanine uptake by peripheral tissues and, more specifically, skeletal muscle and increase intramuscular carnosine synthesis. A crossover counterbalanced study will be conducted. The volunteers will be evaluated in two conditions: intake of B-alanine + exercise (B-EX) and B-alanine intake only (B-Ala). The dosage will be 20 mg · kg-1 (powder diluted in water). This process will be divided into two blocks of six days (Thursday to Thursday - without the weekend) with a 4-6 weeks washout. In the B-EX block, a 20-minute HIIE session will be held. Next, B-alanine supplementation will be administered. Immediately after exercise, in a 150-minute rest, collections of venous blood samples will be performed, and the muscle biopsy and urine collection will be collected pre-test and post-test. In the next three days (Thursday to Wednesday), this same protocol will be repeated without blood, muscle, or urine collections. On these days, the B-alanine supplementation will be administrated before and after the protocol (B-EX and B-Ala), in the same dosage of 20mg.kg-1. On the 6th day (Thursday), the complete protocol will be carried out, including the collection of biological materials. In the B-Ala block, the same procedures will be adopted for the B-EX block, with the replacement of the HIIE for 20 minutes of rest sitting on the cycle ergometer. The nutritional parameters will be evaluated during the two blocks by dietary diaries in software (Dietbox) that includes images and the description of all the volunteer food in the day. It will be determined that during the blocks (B-EX and B-ala), the Beta-alanine intake by food is limited to 300mg per day. The analysis of the determination of muscle B-alanine, plasma, and urine, muscle carnosine will be performed by HPLC-ESI + -MS / MS. The gene expression of carnosine-related enzymes and transporters will be analyzed using the real-time PCR technique. The enzymes CARNS1, CN2, TauT, PAT1, and phosphorylated Na + / K + / ATPase will be analyzed using the Western Blot technique. Carnosine synthase activity will be carried out by incorporating [3H] B-alanine acid in the corresponding dipeptide. The analysis of paresthesia's presence and intensity will be through a scale adapted from LINGJÆRDE et al., 1987. The statistical analysis will be performed in the RStudio software and SAS software, using the mixed model to compare muscle, plasma, and urinary variables. Condition (B-Ex vs. B-ala) and time of collection (time) will be fixed factors, while the subjects will be random factors. Data sets containing values obtained at only 2 points in time (e.g., area below the plasma B-alanine curve) will be analyzed using Student's t-test for dependent samples if the data distribution is normal. If the data distribution is not normal, we will use the Wilcoxon sign test for pairs. The normality of data distribution will be assessed qualitatively using Q-Q Plot. Four different covariance matrix structures will be tested for each data set. The Schwarz-Bayesian criterion (lowest BIC value) will be used to select the matrix that best fits each data set. Hypothesis-guided contrast analysis of a single degree of freedom will test specific effects within and between conditions. The size of the Cohen effect (D) will be calculated for all variables. Significance will be accepted if p<0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The order of treatments will be random
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine supplementation and high intensity exercise | Experimental | Dietary Supplement: Beta-alanine supplementation, Other: High intensity interval exerciseIndividuals will participate in a high-intensity exercise and will be supplemented with beta-alanine. This protocol will be conducted for six non-consecutive days. |
| Beta-alanine supplementation only | Experimental | Dietary Supplement: Beta-alanine supplementationIn this protocol, the individuals will be supplemented with beta-alanine without the exercise protocol for six non-consecutive days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- omnivorous diet for> 6 months
- practice physical activities for> 2 h · week-1
- stable body mass (variation <2 kg in the last 30 days)
Key exclusion criteria (5 listed)
- use of food supplements in the last six months containing β-alanine
- diagnosis of chronic diseases or any other condition that prevents them from performing the proposed procedures
- smoking
- current or past use of anabolic steroids or other ergogenic drugs
- Use of medications that may affect the assessments in this study, including insulin, GH, and thyroid hormone
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-alanine supplementationThe supplementation will be administrated in the dosage of 20mg.kg-1. On the first and the sixth (last one), one dose of beta-alanine will be taken. On the other four days of supplementation, the volunteers will take 2 doses (20mg.kg-1) of Beta-alanine. | Dietary supplement | Beta-alanine supplementation and high intensity exercise, Beta-alanine supplementation only |
| High intensity interval exerciseThe HIIE sessions will consist of 10 series of 1 min of effort, divided into two blocks of 5 series each. There will be an interval of 5 min of passive recovery; within each block, the interval between sets will be 1 min of active recovery. The exercise will be conducted in a mechanical brake cycle ergometer, with load applied by placing washers on a load plate (Biotec 2100, Cefise, Brazil). | Other | Beta-alanine supplementation and high intensity exercise |
Primary outcome
Change from Baseline Muscle Carnosine after B-alanina supplementation
Time frame: This evaluation will be carried out with the muscle samples collected on the first and the sixth (last) day of the protocol.
HPLC-ESI+-MS/MS
Change from Baseline Plasma Beta-alanine after B-alanina supplementation
Time frame: This evaluation will be carried out with the blood samples collected on the first and the sixth (last) day of the protocol
HPLC-ESI+-MS/MS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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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.
Gabriella B Möller, Msc 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 Beta-alanine supplementation and High intensity interval exercise in people with Exercise Training and Carnosine, 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 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: status not confirmed, as of the sponsor's last update on 23 Jun 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 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. 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?
Contact Guilherme G Artioli, Phd (+551126481337, artioli@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Muscle Carnosine after B-alanina supplementation (time frame: This evaluation will be carried out with the muscle samples collected on the first and the sixth (last) day of the protocol.). The study lists 2 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 23 Jun 2021.