Sport PerformanceNCT07135934
Effects of Single Sodium Bicarbonate Supplementation on National-Level Finswimming Performance
A study testing Sodium Bicarbonate (NaHCO3) in people with Sport Performance and Acid Base Imbalance, run by Palacky University at 1 site in Czechia.
Trial summary
This randomized, double-blind, placebo-controlled crossover trial will investigate the acute effects of sodium bicarbonate supplementation on performance, stroke biomechanics, and selected physiological and perceptual responses during a simulated 200-meter Bi-Fins race in elite finswimmers. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Performance, Acid Base Imbalance, Ergogenic Support
- What is being tested?
- Sodium Bicarbonate (NaHCO3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Member of a wider national selection in finswimming (junior or senior level)
- Regular participation in competitive finswimming training (≥4 sessions per week)
- Age between 15 and 30 years
- Absence of chronic illness or injury
- No use of medications or dietary supplements during the study period
- Signed informed consent (for minors, also signed by a legal guardian)
Who cannot join
- History of gastrointestinal disorders affecting supplement tolerance
- Presence of cardiovascular, metabolic, or musculoskeletal disorders
- Current illness or acute infection
- Regular use of substances that may interfere with acid-base balance
- Refusal to comply with pre-test restrictions (e.g., 48 hours without training)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Palacký University, Faculty of Physical Culture
Olomouc, Olomouc Region, 77900
Tomáš Michalica, Mgr., +420605320688, tomas.michalica01@upol.cz
About this study
Official title: Evaluation of the Effects of Single Sodium Bicarbonate Supplementation on Finswimming Performance of National Level Finswimmers: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
This randomized, double-blind, placebo-controlled crossover trial will investigate the acute effects of sodium bicarbonate supplementation on performance, stroke biomechanics, and selected physiological and perceptual responses during a simulated 200-meter Bi-Fins race in elite finswimmers.
Read the detailed description
This randomized, double-blind, placebo-controlled, crossover study will examine the effects of sodium bicarbonate (NaHCO₃) supplementation on simulated finswimming performance and associated biomechanical, physiological, and perceptual responses in national-level finswimmers. Twenty participants, all active members of the Czech junior or senior national team, will complete three test sessions separated by a 48-hour recovery period without training sessions.
The first session will serve as a control with no intervention, while the second and third will involve ingestion of either sodium bicarbonate (NaHCO₃; 300 mg·kg-¹) or placebo (food-grade starch), administered in a randomized, counterbalanced order. The capsules will be indistinguishable in appearance, weight, and texture. Allocation concealment will be ensured: only a designated medical professional overseeing the health and safety of the participants will have access to the randomization codes. Neither the participants nor the investigators will be aware of the supplement condition during testing.
All sessions will be conducted under standardized conditions in a 25-meter indoor swimming pool (Aplikační centrum BALUO, Palacký University Olomouc) and will include a standardized warm-up followed by a 200-meter Bi-Fins time trial.
Blood samples for acid-base balance assessment will be collected at four time points: baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise. From these samples, variability in acid-base balance will be assessed, specifically using actual base excess (ABE; mmol/L), blood hydrogen ion concentration (pH; unitless), and bicarbonate concentration (HCO₃-; mmol/L). Blood lactate concentration (mmol/L) will be measured at two time points only: baseline (10 minutes before warm-up) and 3 minutes post-exercise.
Subjective perceptual responses will include:
- rate of perceived exertion (RPE) using the Borg Category Ratio 1-10 scale, assessed immediately after the race, where higher scores indicate greater exertion;
- gastrointestinal discomfort using the Borg Category Ratio 1-10 scale, assessed approximately 5 minutes before the race to avoid performance bias, where higher scores indicate worse discomfort; and
- delayed-onset muscle soreness (DOMS) using a 10-centimeter visual analog scale (VAS; 0 cm = no soreness, 10 cm = extreme soreness) for both upper and lower limbs, where higher scores indicate greater soreness.
Stroke mechanics - stroke rate (SR; cycles/min) and stroke length (SL; meters/cycle) - will be analyzed from video recordings of the 200-meter trials.
The study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for crossover trials and has been approved by the Ethics Committee of the Faculty of Physical Culture, Palacký University Olomouc (Ref. No. 2/2024).
Statistical analysis will include repeated-measures analysis of variance (ANOVA) to compare conditions and time points. In case of violation of assumptions, appropriate corrections or non-parametric alternatives will be applied. Descriptive statistics, effect sizes (partial eta-squared, Cohen's d), and correlation coefficients (Pearson's r) will be used to support the interpretation of results. Data will be processed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software and Microsoft Excel.
- Conditions
- Sport Performance, Acid Base Imbalance, Ergogenic Support, Sodium Bicarbonate, Water Sports, Biomechanics
- Being tested
- Sodium Bicarbonate (NaHCO3), Placebo
- Keywords
- Sodium Bicarbonate, Stroke Rate, Finswimming, Stroke Length, Athletes, Biomechanics, Gastrointestinal Discomfort, Rate of Perceived Exertion
- Medical subject headings
- Acid-Base Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate (NaHCO3)Dietary supplement
Gelatin capsules each containing 1g sodium bicarbonate (NaHCO₃)
PlaceboDietary supplement
Gelatin capsules each containing 1g food-grade starch
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Placebo: Food-grade starch Participants will ingest 300 mg·kg-¹ body mass of food-grade starch encapsulated in gelatin capsules 60-90 minutes prior to the simulated 200 m Bi-Fins race.
Dietary Supplement: Placebo Gelatin capsules filled with food-grade starch, indistinguishable in appearance from sodium bicarbonate capsules. Water is consumed ad libitum during ingestion.
Other Names: Placebo Capsules Receives: Dietary Supplement: Placebo |
| Sodium Bicarbonate (NaHCO₃) | Experimental | Sodium Bicarbonate: NaHCO₃ Participants will ingest 300 mg·kg-¹ body mass of sodium bicarbonate encapsulated in gelatin capsules 60-90 minutes prior to the simulated 200 m Bi-Fins race.
Dietary Supplement: Sodium Bicarbonate Gelatin capsules containing sodium bicarbonate (NaHCO₃), matched in appearance, weight, and texture to placebo. Water is consumed ad libitum during ingestion.
Other Names: NaHCO₃ Capsules Receives: Dietary Supplement: Sodium Bicarbonate (NaHCO3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke rate (SR; cycles/min)
Calculated from video analysis to determine the number of stroke cycles per minute.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Total race time (seconds)
Total time to complete the 200-meter Bi-Fins time trial, measured using an electronic timing system. Lower values indicate better performance.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Stroke length (SL; meters/cycle)
Calculated from video analysis to determine the average distance traveled per stroke cycle.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Secondary outcomes (10)
Underwater distance (meters)
Distance traveled underwater after the start and turns, measured from video footage of the 200-meter Bi-Fins time trial. Greater values indicate a longer underwater phase.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Blood lactate concentration (mmol/L)
Measured from capillary blood samples to assess anaerobic metabolism. Higher values indicate greater lactate accumulation.
Measured: Baseline (10 minutes before warm-up) and 3 minutes post-exercise on each testing day
Actual base excess (ABE; mmol/L)
Measured from capillary blood samples to assess buffering capacity. More negative values indicate greater metabolic acidosis.
Measured: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Blood bicarbonate concentration (HCO₃-; mmol/L)
Measured from capillary blood samples to assess bicarbonate availability for acid buffering. Lower values indicate reduced buffering capacity.
Measured: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Rate of Perceived Exertion (RPE; score on Borg Category Ratio 1-10 scale)
The Borg Category Ratio 1-10 scale ranges from 1 (no exertion at all) to 10 (maximal exertion). Higher scores indicate greater exertion.
Measured: Immediately post-exercise on each testing day
Gastrointestinal discomfort (score on Borg Category Ratio 1-10 scale)
The Borg Category Ratio 1-10 scale ranges from 1 (no discomfort) to 10 (severe discomfort). Higher scores indicate worse discomfort.
Measured: Approximately 5 minutes before race start on each testing day
Delayed-onset muscle soreness (DOMS; score on 10-centimeter visual analog scale)
The visual analog scale (VAS) ranges from 0 cm (no soreness) to 10 cm (extreme soreness). Higher scores indicate greater soreness.
Measured: Immediately post-exercise on each testing day
Underwater time (seconds)
Time spent underwater after the start and turns, measured from video footage of the 200-meter Bi-Fins time trial. Greater values indicate a longer underwater phase.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Underwater velocity (meters/second)
Average velocity during the underwater phase after the start and turns, measured from video footage of the 200-meter Bi-Fins time trial. Higher values indicate faster underwater performance.
Measured: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Blood hydrogen ion concentration (pH; unitless)
Measured from capillary blood samples to assess acid-base balance. Higher or lower values indicate changes in blood acidity.
Measured: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jul 2025
- Primary completion17 Aug 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport PerformanceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomáš Michalica, Palacky University
- Investigators
- Tomáš Michalica, Mgr., Principal investigator, Palacký University, Faculty of Physical Culture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135934
- Sponsor's protocol ID
- FTK_2024_002
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Single Sodium Bicarbonate Supplementation on Finswimming Performance of National Level Finswimmers: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07135934
- Acronym / sponsor ID
- FTK_2024_002
- Conditions
- Sport Performance, Acid Base Imbalance, Ergogenic Support, Sodium Bicarbonate, Water Sports, Biomechanics
- Keywords
- Sodium Bicarbonate, Stroke Rate, Finswimming, Stroke Length, Athletes, Biomechanics, Gastrointestinal Discomfort, Rate of Perceived Exertion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 17 Aug 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (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.
This randomized, double-blind, placebo-controlled crossover trial will investigate the acute effects of sodium bicarbonate supplementation on performance, stroke biomechanics, and selected physiological and perceptual responses during a simulated 200-meter Bi-Fins race in elite finswimmers.
Detailed description
This randomized, double-blind, placebo-controlled, crossover study will examine the effects of sodium bicarbonate (NaHCO₃) supplementation on simulated finswimming performance and associated biomechanical, physiological, and perceptual responses in national-level finswimmers. Twenty participants, all active members of the Czech junior or senior national team, will complete three test sessions separated by a 48-hour recovery period without training sessions.
The first session will serve as a control with no intervention, while the second and third will involve ingestion of either sodium bicarbonate (NaHCO₃; 300 mg·kg-¹) or placebo (food-grade starch), administered in a randomized, counterbalanced order. The capsules will be indistinguishable in appearance, weight, and texture. Allocation concealment will be ensured: only a designated medical professional overseeing the health and safety of the participants will have access to the randomization codes. Neither the participants nor the investigators will be aware of the supplement condition during testing.
All sessions will be conducted under standardized conditions in a 25-meter indoor swimming pool (Aplikační centrum BALUO, Palacký University Olomouc) and will include a standardized warm-up followed by a 200-meter Bi-Fins time trial.
Blood samples for acid-base balance assessment will be collected at four time points: baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise. From these samples, variability in acid-base balance will be assessed, specifically using actual base excess (ABE; mmol/L), blood hydrogen ion concentration (pH; unitless), and bicarbonate concentration (HCO₃-; mmol/L). Blood lactate concentration (mmol/L) will be measured at two time points only: baseline (10 minutes before warm-up) and 3 minutes post-exercise.
Subjective perceptual responses will include:
- rate of perceived exertion (RPE) using the Borg Category Ratio 1-10 scale, assessed immediately after the race, where higher scores indicate greater exertion;
- gastrointestinal discomfort using the Borg Category Ratio 1-10 scale, assessed approximately 5 minutes before the race to avoid performance bias, where higher scores indicate worse discomfort; and
- delayed-onset muscle soreness (DOMS) using a 10-centimeter visual analog scale (VAS; 0 cm = no soreness, 10 cm = extreme soreness) for both upper and lower limbs, where higher scores indicate greater soreness.
Stroke mechanics - stroke rate (SR; cycles/min) and stroke length (SL; meters/cycle) - will be analyzed from video recordings of the 200-meter trials.
The study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for crossover trials and has been approved by the Ethics Committee of the Faculty of Physical Culture, Palacký University Olomouc (Ref. No. 2/2024).
Statistical analysis will include repeated-measures analysis of variance (ANOVA) to compare conditions and time points. In case of violation of assumptions, appropriate corrections or non-parametric alternatives will be applied. Descriptive statistics, effect sizes (partial eta-squared, Cohen's d), and correlation coefficients (Pearson's r) will be used to support the interpretation of results. Data will be processed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software and Microsoft Excel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Dietary Supplement: PlaceboPlacebo: Food-grade starch Participants will ingest 300 mg·kg-¹ body mass of food-grade starch encapsulated in gelatin capsules 60-90 minutes prior to the simulated 200 m Bi-Fins race. Dietary Supplement: Placebo Gelatin capsules filled with food-grade starch, indistinguishable in appearance from sodium bicarbonate capsules. Water is consumed ad libitum during ingestion. Other Names: Placebo Capsules |
| Sodium Bicarbonate (NaHCO₃) | Experimental | Dietary Supplement: Sodium Bicarbonate (NaHCO3)Sodium Bicarbonate: NaHCO₃ Participants will ingest 300 mg·kg-¹ body mass of sodium bicarbonate encapsulated in gelatin capsules 60-90 minutes prior to the simulated 200 m Bi-Fins race. Dietary Supplement: Sodium Bicarbonate Gelatin capsules containing sodium bicarbonate (NaHCO₃), matched in appearance, weight, and texture to placebo. Water is consumed ad libitum during ingestion. Other Names: NaHCO₃ Capsules |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Member of a wider national selection in finswimming (junior or senior level)
- Regular participation in competitive finswimming training (≥4 sessions per week)
- Age between 15 and 30 years
- Absence of chronic illness or injury
- No use of medications or dietary supplements during the study period
Key exclusion criteria (5 listed)
- History of gastrointestinal disorders affecting supplement tolerance
- Presence of cardiovascular, metabolic, or musculoskeletal disorders
- Current illness or acute infection
- Regular use of substances that may interfere with acid-base balance
- Refusal to comply with pre-test restrictions (e.g., 48 hours without training)
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 (NaHCO3)Gelatin capsules each containing 1g sodium bicarbonate (NaHCO₃) | Dietary supplement | Sodium Bicarbonate (NaHCO₃) |
| PlaceboGelatin capsules each containing 1g food-grade starch | Dietary supplement | Placebo Comparator |
Primary outcome
Stroke rate (SR; cycles/min)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Calculated from video analysis to determine the number of stroke cycles per minute.
Total race time (seconds)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Total time to complete the 200-meter Bi-Fins time trial, measured using an electronic timing system. Lower values indicate better performance.
Stroke length (SL; meters/cycle)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Calculated from video analysis to determine the average distance traveled per stroke cycle.
10 secondary outcomes
Underwater distance (meters)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Blood lactate concentration (mmol/L)
Time frame: Baseline (10 minutes before warm-up) and 3 minutes post-exercise on each testing day
Actual base excess (ABE; mmol/L)
Time frame: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Blood bicarbonate concentration (HCO₃-; mmol/L)
Time frame: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Rate of Perceived Exertion (RPE; score on Borg Category Ratio 1-10 scale)
Time frame: Immediately post-exercise on each testing day
Gastrointestinal discomfort (score on Borg Category Ratio 1-10 scale)
Time frame: Approximately 5 minutes before race start on each testing day
Delayed-onset muscle soreness (DOMS; score on 10-centimeter visual analog scale)
Time frame: Immediately post-exercise on each testing day
Underwater time (seconds)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Underwater velocity (meters/second)
Time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.
Blood hydrogen ion concentration (pH; unitless)
Time frame: Baseline (10 minutes before warm-up), 10 minutes after warm-up, 5 minutes before race start, and 3 minutes post-exercise on each testing day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Tomáš Michalica, Mgr. principal investigator
Palacký University, Faculty of Physical Culture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate (NaHCO3) in people with Sport Performance and Acid Base Imbalance, run by Palacky University at 1 site in Czechia.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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 Czechia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomáš Michalica, Mgr. (+420605320688, tomas.michalica01@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke rate (SR; cycles/min) (time frame: Measured from video analysis of the 200-m Bi-Fins trial; final values reported at race completion on Day 1, Day 3, and Day 5.). The study lists 3 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 22 Aug 2025.