Acute Sodium Bicarbonate Supplementation in Athletes

May 14, 2024 updated by: Krzysztof Durkalec-Michalski, Poznan University of Physical Education

The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance

The purpose of this study is to verify the effect of acute sodium bicarbonate (SB) and placebo (PLA) supplementation on buffering potential kinetics, physical capacity, discipline-specific performance as well as concentration of diagnostically significant blood biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

Effective muscle work is conditioned by maintaining the proper range of muscles pH, regulated by buffering systems, in which the main role is played by bicarbonates (HCO3-). For this reason, sodium bicarbonate (SB) is often proposed as an ergogenic agent, especially during high-intensity efforts. Until now the major limitation to SB supplementation has been the gastrointestinal (GI) side effects. There is also a lack of data of the individual SB-induced changes of buffering potential kinetics and its actual connection with physical capacity and discipline-specific performance. Therefore, this study aims to examine the effect of acute, different-dose SB ingestion on buffering potential kinetics, physical capacity, discipline-specific performance as well as changes of diagnostically significant blood biochemical indices concentration in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

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 (Estimated)

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.
50

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.
  • Phase 3

Contacts and Locations

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

Study Locations

  • Poland
      • Poznań, Poland, 61-871
        • Department of Sports Dietetics, Poznan University of Physical Education

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

Description

Inclusion Criteria:

  • written consent to participate,
  • a current medical clearance to practice sports,
  • training experience: at least 2 years,
  • minimum of 4 workout sessions (in the discipline covered by the study) a week.

Exclusion Criteria:

  • current injury,
  • any health-related contraindication,
  • declared general feeling of being unwell,
  • unwilling to follow the study protocol.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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: Sodium bicarbonate supplementation
Group taking oral SB supplementation in a different-dose regimen.
Dietary supplement: Sodium bicarbonate supplementation

Interventions:

The experimental procedure for each athlete included an acute SB supplementation in a different-dose regimen in order to assess whether the dose affects the actual physical and exercise capacity (doses: 0.15-, 0.25-, 0.35- and 0.50 g/kgFFM (0.12-, 0.20-, 0.28- and 0.40 g/kgBM), respectively). SB (Alkala, SANUM, Poland) will be administered as dissolved form in a 750 ml of fluid (water + fruit juice). On testing days the SB will be taken before physical and exercise capacity tests session.

Between the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced.
Placebo Comparator: Placebo treatment
Group taking oral supplementation with placebo (NaCl).
Dietary supplement: Placebo treatment

Interventions:

The experimental procedure for each athlete will be included an PLA supplementation. Placebo will be administered in a form of 750 ml of fluid (water + fruit juice). On testing days the PLA will be taken before physical and exercise capacity tests session.

Between the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced.

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
Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
The Wingate cycling test carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes in discipline-specific exercise capacity after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of bicarbonate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Bicarbonate (HCO3-) [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of base excess concentration in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Base excess [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Lactate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Pyruvate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Glucose [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Hemoglobin (Hb) [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of blood cells concentration in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Blood cells [mln/mm³] concentration analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of creatine kinase activity in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Creatine kinase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation
Changes of lactate dehydrogenase activity in blood after sodium bicarbonate supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
Lactate dehydrogenase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
Baseline and during 1 day of acute SB and PLA supplementation

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.
Poznan University of Physical Education

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: Krzysztof Durkalec-Michalski, Prof., PhD, Department of Sports Dietetics, Poznan University of Physical Education

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.
December 20, 2018

Primary Completion (Estimated)

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.
November 1, 2024

Study Completion (Estimated)

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.
January 20, 2025

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).
January 14, 2019

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.
January 17, 2019

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.
January 18, 2019

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.
May 16, 2024

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.
May 14, 2024

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.
May 1, 2024

More Information

Terms related to this study

Keywords

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.
  • ULS00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal.

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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