SupplementationPhase 2/3NCT03406065
Sodium Bicarbonate Supplementation in Combat Sports Athletes
A Phase 2/3 study testing Sodium bicarbonate supplementation in people with Supplementation and Sport, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 to 30 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
- 64 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2014to 5 Apr 2015
- Phase
- Phase 2/3
- 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 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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,
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
Poznan University of Life Sciences, ul.Wojska Polskiego 31
Poznan, Wielkopolska, 60-624
About this study
Official title: 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.
Read the 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.
- Conditions
- Supplementation, Sport
- Being tested
- Sodium bicarbonate supplementation, Placebo treatment
- Keywords
- Sodium bicarbonate, NaHCO3, Combat Sports, Physical capacity, Dummy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate supplementationDietary supplement
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 treatmentDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate supplementation | Experimental | Group taking oral NaHCO3 supplementation in a progressive-dose regimen. Receives: Dietary Supplement: Sodium bicarbonate supplementation |
| Placebo treatment | Placebo comparator | Group taking oral supplementation with placebo (maltodextrin with NaCl) in a similar tablet form prepared by the same producer as NaHCO3 tablets. 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
The Wingate Anaerobic Test (WAnT)
Measured: Baseline and after 10 days
Changes in specific performance capacity after sodium bicarbonate supplementation
The wrestler's special endurance test - projective test with dummy (DT)
Measured: Baseline and after 10 days
Secondary outcomes (7)
Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation
Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis
Measured: Baseline and after 10 days
Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation
Creatine kinase [U/L] and lactate dehydrogenase [U/L] activity analysis
Measured: Baseline and after 10 days
Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation
Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis
Measured: Baseline and after 10 days
Changes in blood hematocrit levels after sodium bicarbonate supplementation
Hematocrit (HCT) [%] level analysis
Measured: Baseline and after 10 days
Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation
Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis
Measured: Baseline and after 10 days
Changes in polyphenols and albumin concentration
Polyphenols [g/L] and and albumin [g/L] concentration analysis
Measured: Baseline and after 10 days
Changes in FRAP concentration
FRAP [µmol/L] concentration analysis
Measured: Baseline and after 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start10 Oct 2014
- Primary completion20 Jan 2015
- Study completion5 Apr 2015
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of PhysED
- Responsible party
- Sponsor
- Investigators
- Jan Jeszka, Professor, Study chair, Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406065
- Sponsor's protocol ID
- ULS00003
- Status last verified
- Jan 2018
- First submitted
- 14 Jan 2018
- Last updated
- 23 Jan 2018
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Bicarbonate Supplementation on Physical and Specific Performance Capacity in Combat Sports Athletes
- ClinicalTrials.gov ID
- NCT03406065
- Acronym / sponsor ID
- ULS00003
- Conditions
- Supplementation, Sport
- Keywords
- Sodium bicarbonate, NaHCO3, Combat Sports, Physical capacity, Dummy test
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Collaborators
- Poznan University of PhysED
- Study start
- 10 Oct 2014 (actual)
- Primary completion
- 20 Jan 2015 (actual)
- Study completion
- 5 Apr 2015 (actual)
- First posted
- 23 Jan 2018 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 NaHCO3 supplementation in a progressive-dose regimen. |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentGroup taking oral supplementation with placebo (maltodextrin with NaCl) in a similar tablet form prepared by the same producer as NaHCO3 tablets. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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,
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 supplementationThe 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. | Dietary supplement | Sodium bicarbonate supplementation |
| Placebo treatmentThe 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. | Dietary supplement | Placebo treatment |
Primary outcome
Changes in anaerobic capacity after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
The Wingate Anaerobic Test (WAnT)
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)
7 secondary outcomes
Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation
Time frame: 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
Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
Changes in blood hematocrit levels after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
Changes in polyphenols and albumin concentration
Time frame: Baseline and after 10 days
Changes in FRAP concentration
Time frame: Baseline and after 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided. 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.
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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. This study is not recruiting at the moment.
Jan Jeszka, Professor study chair
Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium bicarbonate supplementation in people with Supplementation and Sport, run by Poznan University of Life Sciences 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline and after 10 days). The study lists 2 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 23 Jan 2018.