Sodium Bicarbonate Supplementation in Combat Sports Athletes

January 14, 2018 updated by: Poznan University of Life Sciences

The Effect of Sodium Bicarbonate Supplementation on Physical and Specific Performance Capacity in Combat Sports Athletes

The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and placebo (PLA) supplementation on physical and specific performance capacity, as well as concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.

Study Overview

Status

Status

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

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

Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves high-intensity and resistance exercise performance. Until now the major limitation to NaHCO3 supplementation has been the gastrointestinal (GI) side effects. Therefore, this study aims to examine the effect of chronic, progressive-dose NaHCO3 ingestion on physical capacity and specific performance capacity, and concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled 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 (Actual)

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.
64

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 2
  • 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
    • Wielkopolska
      • Poznań, Wielkopolska, Poland, 60-624
        • Poznan University of Life Sciences, ul.Wojska Polskiego 31

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

17 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent from all participants before the study (included aslo informed consents to the participation in the study of athletes under the age of 18 obtained from their parents)
  • a current medical clearance to practice sports,
  • training experience: at least 4 years (of combat sport training),
  • minimum of 4 workout sessions (combat sport) 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: Parallel 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 NaHCO3 supplementation in a progressive-dose regimen.
Dietary supplement: Sodium bicarbonate supplementation
The experimental procedure for each athlete included a 10-day NaHCO3 supplementation in a progressive-dose regimen in order to reduce the likelihood of gastrointestinal side effects (from 25 to 100 mg ∙ kg-1). NaHCO3 was administered in the form of unmarked disk-shaped tablets (Alkala T, SANUM, Poland). The tablets were ingested with at least 250 mL of water and could be either swallowed or dissolved in the mouth. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.
Placebo Comparator: Placebo treatment
Group taking oral supplementation with placebo (maltodextrin with NaCl) in a similar tablet form prepared by the same producer as NaHCO3 tablets.
Dietary supplement: Placebo treatment
The experimental procedure for each athlete included a 10-day placebo administration. Placebo was ingested with at least 250 mL of water. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.

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
Time Frame: Baseline and after 10 days
The Wingate Anaerobic Test (WAnT)
Baseline and after 10 days
Changes in specific performance capacity after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
The wrestler's special endurance test - projective test with dummy (DT)
Baseline and after 10 days

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 red and white blood cell concentration in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis
Baseline and after 10 days
Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis
Baseline and after 10 days
Changes in blood hematocrit levels after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
Hematocrit (HCT) [%] level analysis
Baseline and after 10 days
Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis
Baseline and after 10 days
Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
Creatine kinase [U/L] and lactate dehydrogenase [U/L] activity analysis
Baseline and after 10 days
Changes in polyphenols and albumin concentration
Time Frame: Baseline and after 10 days
Polyphenols [g/L] and and albumin [g/L] concentration analysis
Baseline and after 10 days
Changes in FRAP concentration
Time Frame: Baseline and after 10 days
FRAP [µmol/L] concentration analysis
Baseline and after 10 days

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 Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Poznan University of PhysED

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.
  • Study Chair: Jan Jeszka, Professor, Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624

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.
October 10, 2014

Primary Completion (Actual)

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.
January 20, 2015

Study Completion (Actual)

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.
April 5, 2015

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, 2018

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 14, 2018

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 23, 2018

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.
January 23, 2018

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.
January 14, 2018

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.
January 1, 2018

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.
  • ULS00003

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 recorded indicators (anaerobic capacity and specific performance capacity indicators, levels of biochemical markers, body composition), 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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