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Acute Sodium Bicarbonate Supplementation in Athletes

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ClinicalTrials.gov Identifier: NCT03810404
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Poznan University of Physical Education
Information provided by (Responsible Party):
Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Supplementation Sport Dietary Supplement: Sodium bicarbonate supplementation Dietary Supplement: Placebo treatment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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- and 0,35 g/kgFFM, respectively). SB (Alkala T, SANUM, Poland) will be administered as dissolved form in a 600 ml of fluid (water + fruit juice). On testing days the supplements will be taken 2 hours 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 600 ml of fluid (water + fruit juice). On testing days the PLA will be taken 2 hours 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.





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810404


Contacts
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Contact: Krzysztof Durkalec-Michalski, PhD +48 618 487 338 durkmich@up.poznan.pl

Locations
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Poland
Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences Recruiting
Poznań, Poland, 60-624
Contact: Krzysztof Durkalec-Michalski, PhD    +48 618 487 338    durkmich@up.poznan.pl   
Sub-Investigator: Tomasz Podgórski, PhD         
Sponsors and Collaborators
Poznan University of Life Sciences
Poznan University of Physical Education
Investigators
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Principal Investigator: Krzysztof Durkalec-Michalski, PhD Poznan University of Life Sciences

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Responsible Party: Krzysztof Durkalec-Michalski, PhD, Principal Investigator, Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03810404     History of Changes
Other Study ID Numbers: ULS00006
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences:
Sports nutrition
Sodium bicarbonate
Physical capacity
Exercise performance
Buffering potential
Biochemical markers