<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810404</url>
  </required_header>
  <id_info>
    <org_study_id>ULS00006</org_study_id>
    <nct_id>NCT03810404</nct_id>
  </id_info>
  <brief_title>Acute Sodium Bicarbonate Supplementation in Athletes</brief_title>
  <official_title>The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Physical Education</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the effect of acute sodium bicarbonate (SB) and&#xD;
      placebo (PLA) supplementation on buffering potential kinetics, physical capacity,&#xD;
      discipline-specific performance as well as concentration of diagnostically significant blood&#xD;
      biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effective muscle work is conditioned by maintaining the proper range of muscles pH, regulated&#xD;
      by buffering systems, in which the main role is played by bicarbonates (HCO3-). For this&#xD;
      reason, sodium bicarbonate (SB) is often proposed as an ergogenic agent, especially during&#xD;
      high-intensity efforts. Until now the major limitation to SB supplementation has been the&#xD;
      gastrointestinal (GI) side effects. There is also a lack of data of the individual SB-induced&#xD;
      changes of buffering potential kinetics and its actual connection with physical capacity and&#xD;
      discipline-specific performance. Therefore, this study aims to examine the effect of acute,&#xD;
      different-dose SB ingestion on buffering potential kinetics, physical capacity,&#xD;
      discipline-specific performance as well as changes of diagnostically significant blood&#xD;
      biochemical indices concentration in athletes, in a randomised, double-blind,&#xD;
      placebo-controlled crossover trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>The Wingate cycling test carried out at baseline, and after SB and PLA supplementation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in discipline-specific exercise capacity after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of bicarbonate concentration in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Bicarbonate (HCO3-) [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of base excess concentration in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Base excess [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Lactate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Pyruvate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Glucose [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Hemoglobin (Hb) [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of blood cells concentration in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Blood cells [mln/mm³] concentration analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of creatine kinase activity in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Creatine kinase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lactate dehydrogenase activity in blood after sodium bicarbonate supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute SB and PLA supplementation</time_frame>
    <description>Lactate dehydrogenase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Supplementation</condition>
  <condition>Sport</condition>
  <arm_group>
    <arm_group_label>Sodium bicarbonate supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group taking oral SB supplementation in a different-dose regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group taking oral supplementation with placebo (NaCl).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sodium bicarbonate supplementation</intervention_name>
    <description>Interventions:&#xD;
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.&#xD;
Between the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced.</description>
    <arm_group_label>Sodium bicarbonate supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo treatment</intervention_name>
    <description>Interventions:&#xD;
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.&#xD;
Between the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced.</description>
    <arm_group_label>Placebo treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent to participate,&#xD;
&#xD;
          -  a current medical clearance to practice sports,&#xD;
&#xD;
          -  training experience: at least 2 years,&#xD;
&#xD;
          -  minimum of 4 workout sessions (in the discipline covered by the study) a week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current injury,&#xD;
&#xD;
          -  any health-related contraindication,&#xD;
&#xD;
          -  declared general feeling of being unwell,&#xD;
&#xD;
          -  unwilling to follow the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krzysztof Durkalec-Michalski, Prof., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Sports Dietetics, Poznan University of Physical Education</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Sports Dietetics, Poznan University of Physical Education</name>
      <address>
        <city>Poznań</city>
        <zip>61-871</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Physical Education</investigator_affiliation>
    <investigator_full_name>Krzysztof Durkalec-Michalski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sports nutrition</keyword>
  <keyword>Sodium bicarbonate</keyword>
  <keyword>Physical capacity</keyword>
  <keyword>Exercise performance</keyword>
  <keyword>Buffering potential</keyword>
  <keyword>Biochemical markers</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810404
org study id: ULS00006
nct id: NCT03810404
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment
time frame: Baseline and during 1 day of acute SB and PLA supplementation
description: The Wingate cycling test carried out at baseline, and after SB and PLA supplementation
measure: 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
description: The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Bicarbonate (HCO3-) [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Base excess [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Lactate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Pyruvate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Glucose [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
measure: Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment
time frame: Baseline and during 1 day of acute SB and PLA supplementation
description: Hemoglobin (Hb) [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Blood cells [mln/mm³] concentration analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Creatine kinase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
measure: 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
description: Lactate dehydrogenase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
arm group label: Sodium bicarbonate supplementation
arm group type: Experimental
description: Group taking oral SB supplementation in a different-dose regimen.
arm group label: Placebo treatment
arm group type: Placebo Comparator
description: Group taking oral supplementation with placebo (NaCl).
intervention type: Dietary Supplement
intervention name: Sodium bicarbonate supplementation
description: 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.
arm group label: Sodium bicarbonate supplementation
intervention type: Dietary Supplement
intervention name: Placebo treatment
description: 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.
arm group label: Placebo treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Krzysztof Durkalec-Michalski, Prof., PhD
role: Principal Investigator
affiliation: Department of Sports Dietetics, Poznan University of Physical Education
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Physical Education
investigator full name: Krzysztof Durkalec-Michalski
investigator title: Principal Investigator
sharing ipd: Undecided
ipd 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.