SupplementationPhase 3NCT03165357
Sodium Bicarbonate Supplementation in Athletes
A Phase 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 body composition, physical capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial. Read more about this study
- Who is it for?
- Ages 20 to 43 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
- 26 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2015to 5 Apr 2016
- 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 20 to 43 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 (of CrossFit training),
- minimum of 3 workout sessions (CrossFit) a week,
- 20-43 years.
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 Capacity and Body Composition in Trained Athletes
The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and placebo (PLA) supplementation on body composition, physical capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover 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, body composition and concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.
- Conditions
- Supplementation, Sport
- Being tested
- Sodium bicarbonate supplementation, Placebo treatment
- Keywords
- Crossfit, Sodium bicarbonate, Physical capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate supplementationDietary supplement
Placebo treatmentDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | Group taking oral NaHCO3 supplementation in a progressive-dose regimen.
Interventions:
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 37.5 to 150 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.
Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. Receives: Dietary Supplement: Sodium bicarbonate supplementation |
| Placebo (maltodextrin) | Placebo comparator | Group taking oral supplementation with placebo (maltodextrin).
Interventions:
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.
Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in aerobic capacity after sodium bicarbonate supplementation
The incremental cycling test (ICT)
Measured: Baseline and after 10 days
Changes in specific performance capacity after sodium bicarbonate supplementation
The CrossFit-specific physical fitness test: Fight Gone Bad (FGB)
Measured: Baseline and after 10 days
Secondary outcomes (6)
Changes in fat mass and fat free mass after sodium bicarbonate supplementation
Fat mass (kg) and fat free mass (kg) 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 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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start10 Oct 2015
- Primary completion10 Mar 2016
- Study completion5 Apr 2016
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
- 26 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, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165357
- Sponsor's protocol ID
- ULS00002
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Shared data will be exclusively related to the level recorded indicators (body composition, aerobic and anaerobic capacity indicators, levels of biochemical markers), 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 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Bicarbonate Supplementation on Physical Capacity and Body Composition in Trained Athletes
- ClinicalTrials.gov ID
- NCT03165357
- Acronym / sponsor ID
- ULS00002
- Conditions
- Supplementation, Sport
- Keywords
- Crossfit, Sodium bicarbonate, Physical capacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Collaborators
- Poznan University of PhysED
- Study start
- 10 Oct 2015 (actual)
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 5 Apr 2016 (actual)
- First posted
- 24 May 2017 (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 body composition, physical capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover 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, body composition and concentrations of the selected biochemical blood markers in trained 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 | Experimental | Dietary Supplement: Sodium bicarbonate supplementationGroup taking oral NaHCO3 supplementation in a progressive-dose regimen. Interventions: 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 37.5 to 150 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. Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. |
| Placebo (maltodextrin) | Placebo comparator | Dietary Supplement: Placebo treatmentGroup taking oral supplementation with placebo (maltodextrin). Interventions: 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. Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- written consent to participate,
- a current medical clearance to practice sports,
- training experience: at least 2 years (of CrossFit training),
- minimum of 3 workout sessions (CrossFit) a week,
- 20-43 years.
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 supplementation | Dietary supplement | Sodium bicarbonate |
| Placebo treatment | Dietary supplement | Placebo (maltodextrin) |
Primary outcome
Changes in aerobic capacity after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
The incremental cycling test (ICT)
Changes in specific performance capacity after sodium bicarbonate supplementation
Time frame: Baseline and after 10 days
The CrossFit-specific physical fitness test: Fight Gone Bad (FGB)
6 secondary outcomes
Changes in fat mass and fat free mass 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 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 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
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 24 May 2017.
- Individual participant dataSharing planned: Undecided. Shared data will be exclusively related to the level recorded indicators (body composition, aerobic and anaerobic capacity indicators, levels of biochemical markers), 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
Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
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 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 5 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 24 May 2017. 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?
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 aerobic 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 24 May 2017.