The Influence of Exercise on Tissue Beta-alanine Uptake and Carnosine Synthesis Rates

June 21, 2021 updated by: Bruno Gualano, University of Sao Paulo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Guilherme G Artioli, Phd
  • Phone Number: +551126481337
  • Email: artioli@usp.br

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-030
        • Recruiting
        • University of Sao Paulo
        • Sub-Investigator:
          • Gabriella Möller, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • omnivorous diet for> 6 months
  • practice physical activities for> 2 h · week-1
  • stable body mass (variation <2 kg in the last 30 days)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Beta-alanine supplementation and high intensity exercise
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.
Dietary supplement: Beta-alanine supplementation
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.
Other: High intensity interval exercise
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).
Experimental: Beta-alanine supplementation only
In this protocol, the individuals will be supplemented with beta-alanine without the exercise protocol for six non-consecutive days.
Dietary supplement: Beta-alanine supplementation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
This evaluation will be carried out with the blood samples collected on the first and the sixth (last) day of the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriella B Möller, Msc, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-alanine and HIIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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