SupplementationPhase 3NCT03810404
Acute Sodium Bicarbonate Supplementation in Athletes
A Phase 3 study testing Sodium bicarbonate supplementation in people with Supplementation and Sport, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Sport
- What is being tested?
- Sodium bicarbonate supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 20 Dec 2018to 20 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Sports Dietetics, Poznan University of Physical Education
Poznan, 61-871
About this study
Official title: 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.
Read the 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.
- Conditions
- Supplementation, Sport
- Being tested
- Sodium bicarbonate supplementation, Placebo treatment
- Keywords
- Sports nutrition, Sodium bicarbonate, Physical capacity, Exercise performance, Buffering potential, Biochemical markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate supplementationDietary supplement
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 treatmentDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate supplementation | Experimental | Group taking oral SB supplementation in a different-dose regimen. Receives: Dietary Supplement: Sodium bicarbonate supplementation |
| Placebo treatment | Placebo comparator | Group taking oral supplementation with placebo (NaCl). Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment
The Wingate cycling test carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes in discipline-specific exercise capacity after sodium bicarbonate supplementation and placebo treatment
The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes of bicarbonate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Bicarbonate (HCO3-) [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
Measured: 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
Base excess [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Secondary outcomes (8)
Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment
Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Lactate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment
Pyruvate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment
Glucose [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment
Hemoglobin (Hb) [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation
Measured: 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
Blood cells [mln/mm³] concentration analysis carried out at baseline, and after SB and PLA supplementation
Measured: 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
Creatine kinase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
Measured: 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
Lactate dehydrogenase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation
Measured: Baseline and during 1 day of acute SB and PLA supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start20 Dec 2018
- Primary completion1 Nov 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, Poznan University of Physical Education
- Investigators
- Krzysztof Durkalec-Michalski, Prof., PhD, Principal investigator, Department of Sports Dietetics, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810404
- Sponsor's protocol ID
- ULS00006
- Status last verified
- May 2024
- First submitted
- 14 Jan 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance
- ClinicalTrials.gov ID
- NCT03810404
- Acronym / sponsor ID
- ULS00006
- Conditions
- Supplementation, Sport
- Keywords
- Sports nutrition, Sodium bicarbonate, Physical capacity, Exercise performance, Buffering potential, Biochemical markers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate supplementation | Experimental | Dietary Supplement: Sodium bicarbonate supplementationGroup taking oral SB supplementation in a different-dose regimen. |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentGroup taking oral supplementation with placebo (NaCl). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonate supplementationInterventions: 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. | Dietary supplement | Sodium bicarbonate supplementation |
| Placebo treatmentInterventions: 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. | Dietary supplement | Placebo treatment |
Primary outcome
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
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
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
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
8 secondary outcomes
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
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
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
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
Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Supplementation
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Enrolling by invitation
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Durkalec-Michalski, Prof., PhD principal investigator
Department of Sports Dietetics, Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium bicarbonate supplementation in people with Supplementation and Sport, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.