NCT04936737

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

April 16, 2021

Last Update Submit

June 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Muscle Carnosine after B-alanina supplementation

    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

    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

Study Arms (2)

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.

Dietary Supplement: Beta-alanine supplementationOther: 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.

Dietary Supplement: Beta-alanine supplementation

Interventions

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.

Beta-alanine supplementation and high intensity exerciseBeta-alanine supplementation only

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).

Beta-alanine supplementation and high intensity exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gabriella B Möller, Msc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme G Artioli, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The order of treatments will be random
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

June 23, 2021

Study Start

May 6, 2021

Primary Completion

December 23, 2022

Study Completion

December 31, 2023

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations