SupplementationPhase 3NCT07092930
Effects of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Biochemical Markers Concentrations
A Phase 3 study testing BA and SB supplementation, BA and PL2 supplementation and PL1 and SB supplementation in people with Supplementation and Sports, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
This randomized, double-blind, placebo-controlled, parallel-group study aims to evaluate the potential synergistic effect of beta-alanine (BA) and sodium bicarbonate (SB) supplementation, compared to their separate administration or placebo (PL), on physical performance and selected blood biochemical markers in highly… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Sports, Female Athletes
- What is being tested?
- BA and SB supplementation, BA and PL2 supplementation and PL1 and SB supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2023to Dec 2025
- Phase
- Phase 3
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- written consent to participate,
- general good health condition,
- a current medical clearance to practice sports,
- training experience: at least 4 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,
- taking supplements, especially ergogenic supplements that modulate extra- and intracellular capacity 3 months prior to research (except taking protein and/or carbohydrate powders, isotonic drinks),
- unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Sports Dietetics, Poznan University of Physical Education Poznań
Poznan, Wielkopolska, 61-871
Jakub Adamczewski, MSc, +48 66 317 56 06, adamczewski@awf.poznan.pl
Krzysztof Durkalec-Michalski, PhD, +48 61 835 51 65, durkalec-michalski@awf.poznan.pl
About this study
Official title: Evaluation of the Synergistic Effect of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Blood Biochemical Markers Concentrations in Trained Female Basketball Players
This randomized, double-blind, placebo-controlled, parallel-group study aims to evaluate the potential synergistic effect of beta-alanine (BA) and sodium bicarbonate (SB) supplementation, compared to their separate administration or placebo (PL), on physical performance and selected blood biochemical markers in highly trained female basketball players.
Read the detailed description
Beta-alanine (BA) and sodium bicarbonate (SB) are commonly proposed as ergogenic aids due to their potential to enhance intracellular (BA) and extracellular (SB) buffering capacities, thereby improving physical performance. However, there is a lack of evidence regarding their potential synergistic effects, particularly in female athletes. Existing studies have primarily focused on male participants, despite emerging evidence suggesting sex-specific physiological responses to supplementation. Furthermore, research shows that females exhibit a high willingness to participate in scientific studies, underlining the importance of including female cohorts in sports supplementation research. To date, no randomized, double-blind, placebo-controlled trials have examined the combined and separate effects of BA and SB using a four-arm design (BA+SB, BA+PL2, PL1+SB, PL1+ PL2). Only one study to date has focused on chronic SB supplementation, whereas the majority have used acute protocols. Additionally, there is a notable lack of data on the use of BA and SB in team sports such as basketball, where repeated high-intensity efforts are dominant. Therefore, this study aims to investigate the chronic effects of BA and SB supplementation (administered individually or in combination) on physical capacity and selected blood biochemical markers in highly trained female basketball players, using a randomized, double-blind, placebo-controlled, parallel-group design.
- Conditions
- Supplementation, Sports, Female Athletes
- Being tested
- BA and SB supplementation, BA and PL2 supplementation, PL1 and SB supplementation, PL1 and PL2 supplementation
- Keywords
- Beta-alanine, Sodium bicarbonate, Ergogenic aids, Sports nutrition, Team sports, Physical capacity, Body composition, Blood and urine biochemical markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA and SB supplementationDietary supplement
Assigned Interventions:
- Beta-alanine (BA)
- Sodium bicarbonate (SB)
Description:
- Participants receive beta-alanine and sodium bicarbonate
Intervention list \& supplementation details:
- Beta-alanine (BA)
- Form: Gelatin capsules
- Substance: Pure beta-alanine
- Daily dose: 6.4 g/day
- Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner)
- Supplementation period: days 1 to 28
- Sodium bicarbonate (SB)
- Form: Gelatin capsules
- Substance: Pure sodium bicarbonate
- Daily dose: 0.3 g/kg body mass per day
- Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner)
- Supplementation period: days 21 to 28 of BA or PL1 supplementation
Rationale:
- This group tests the combined effects of BA and SB
BA and PL2 supplementationDietary supplement
Participants in this intervention group will undergo chronic supplementation with beta-alanine (BA) and an inert placebo (PL2) matched to the sodium bicarbonate (SB) protocol.
- Beta-alanine (pure, in gelatin capsules) will be administered at a total daily dose of 6.4 g, divided into four servings taken with meals, over a period of 28 consecutive days.
- PL2 (placebo matched to SB, in gelatin capsules) will be administered from Day 21 to Day 28 of beta-alanine supplementation, at a daily dose of 0.3 g per kg of body mass, divided into three equal servings taken with meals.
This group allows for evaluation of the isolated effects of BA supplementation when combined with a placebo comparator to SB
PL1 and SB supplementationDietary supplement
Assigned Interventions:
- Placebo matched to BA (PL1)
- Sodium bicarbonate (SB)
Description:
- Participants receive only sodium bicarbonate as the active compound and placebo capsules matching the BA protocol.
Intervention list \& supplementation details:
- Placebo matched to BA (PL1)
- Form: Gelatin capsules
- Substance: Inert substance matched in appearance and dosing schedule to BA
- Daily dose: 6.4 g/day
- Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner)
- Supplementation period: days 1 to 28
- Sodium bicarbonate (SB)
- Form: Gelatin capsules
- Substance: Pure sodium bicarbonate
- Daily dose: 0.3 g/kg body mass per day
- Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner)
- Supplementation period: days 21 to 28 of BA or PL1 supplementation
Rationale:
- This group tests the isolated effects of SB
PL1 and PL2 supplementationDietary supplement
Assigned Interventions:
- Placebo matched to BA (PL1)
- Placebo matched to SB (PL2)
Description:
- Participants receive two matched placebos.
Intervention list \& supplementation details:
- Placebo matched to BA (PL1)
- Form: Gelatin capsules
- Substance: Inert substance matched in appearance and dosing schedule to BA
- Daily dose: 6.4 g/day
- Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner)
- Supplementation period: days 1 to 28
- Placebo matched to SB (PL2)
- Form: Gelatin capsules
- Substance: Inert substance matched in appearance and timing to SB
- Daily dose: 0.3 g/kg body mass per day
- Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner)
- Supplementation period: days 21 to 28 of BA or PL1 supplementation
Rationale:
- This serves as the control group for comparison with all active intervention arms.
| Study group | Role | What they receive |
|---|---|---|
| BA and SB supplementation (first group) | Experimental | Not described Receives: Dietary Supplement: BA and SB supplementation |
| BA and PL2 supplementation (second group) | Experimental | Not described Receives: Dietary Supplement: BA and PL2 supplementation |
| PL1 and SB supplementation (third group) | Experimental | Not described Receives: Dietary Supplement: PL1 and SB supplementation |
| PL1 and PL2 supplementation (fourth group) | Placebo comparator | Not described Receives: Dietary Supplement: PL1 and PL2 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT)
Assessment of peak power (PP), average power (AP), minimum power (MP), power drop (PD) [W (Watts)] using the Monark 894E ergometer (measured before and after incremental cycling test (ICT)) before and after supplementation (BA - beta-alanine; SB - sodium bicarbonate; PL - placebo; with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in Countermovement Jump (CMJ) performance
Assessment of three consecutive countermovement jump (CMJ) heights [cm (centimetres)] using the Microgate system, measured at rest and after the entire exercise procedure, both before and after supplementation.
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in aerobic capacity during incremental cycling test (ICT)
Assessment of time to exhaustion [s (seconds)] during an incremental cycling test (ICT) using Ergoline E100P-K, measured before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in blood bicarbonate, base excess, anion gap, and lactate concentrations
Assessment of bicarbonate, base excess, anion gap, lactate [mmol/L] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in hydrogen ion concentration
Assessment of hydrogen ion concentration [nmol/L] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Secondary outcomes (25)
Analysis of dietary energy intake
Assessment of energy intake [kcal (kilocalories)], before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: 48 h before the first study visit and the second study visit after 28 days of intervention.
Analysis of dietary macronutrient intake
Assessment of macronutrients intake (proteins, carbohydrates, fats) [g (grams)], before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: 48 h before the first study visit and the second study visit after 28 days of intervention.
Changes in rate of perceived exertion
The Borg RPE Scale ranges from 6 (no exertion at all) to 20 (maximal exertion). Higher scores indicate greater subjective perceived physical effort. The scale will be administered in accordance with the original methodology described by Borg (1982).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in heart rate
Assessment of heart rate (HR) [bpm (beats per minute)] during the entire exercise procedure, measured before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in gastrointestinal symptoms
Assessment of gastrointestinal (GI) symptoms using the adapted and validated Gastrointestinal and Related Complaints Questionnaire, via a self-reported symptom severity scale [0-10], administered at rest and after the exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
The questionnaire assesses 19 symptoms: stomach problems, nausea, dizziness, headache, flatulence, urge to urinate, urge to defecate, belching, heartburn, bloating, stomach cramps, intestinal cramps, urge to vomit, vomiting, diarrhoea, left side ache, right side ache, muscle cramps, and cold shivering.
Each symptom is rated from 0 (no symptoms) to 10 (severe symptoms). Higher scores indicate greater gastrointestinal symptom severity. The scale will be administered in accordance with the methodology described by Jeukendrup et al. (2000).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in body mass, fat-free mass and fat mass
Assessment of body mass, fat-free mass and fat mass [kg (kilograms)] at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in total body water content
Assessment of total body water, extracellular and intracellular water [% (percentage)] at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in lymphocytes, monocytes, granulocytes, red blood cells and platelets
Assessment of blood cells (WBC), lymphocytes (LYM), monocytes (MON), granulocytes (GRA), red blood cells (RBC) and platelets (PLT) [count/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in platelets distribution width and platelets large cell ratio
Assessment of platelets distribution width (PDW) and platelets large cell ratio (PLCR) [%] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in hemoglobin and mean corpuscular hemoglobin concentration
Assessment of hemoglobin and mean corpuscular hemoglobin concentration [mmol/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in hematocrit
Assessment of hematocrit (HCT) [L/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in mean corpuscular volume, mean platelet volume, red blood cell distribution width
Assessment of hematological markers [fL] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation. The analysis will include mean corpuscular volume (MCV), mean platelet volume (MPV), read blood cell distribution width (RDW) [fL], before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in mean corpuscular hemoglobin
Assessment of mean corpuscular hemoglobin (MCH) [fmol] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in alanine aminotransferase, aspartate aminotransferase, creatine kinase and lactate dehydrogenase
Assessment of alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), creatine kinase (CK) and lactate dehydrogenase (LDH) [U/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urea and magnesium
Assessment of urea and magnesium (Mg) [mmol/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in creatinine
Assessment of creatinine concentration [μmol/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in iron and unsaturated iron binding capacity
Assessment of iron and unsaturated iron binding capacity (UIBC) [μg/dL] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2)
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in transferrin
Assessment of transferrin [g/L] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in ferritin
Assessment of ferritin [μg/mL] will be performed in capillary blood collected at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in potassium, sodium, ionized calcium, chloride, osmolality
Assessment of potassium (cK⁺), sodium (cNa⁺), ionized calcium (cCa²⁺), chloride (cCl-), osmolality (mOsm.c) [mmol/L] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine specific gravity
Assessment of urine specific gravity (USG) measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in protein, glucose, ketones, urobilinogen, bilirubin
Assessment of protein (PRO), glucose (GLU), ketones (KET), urobilinogen (UBG), bilirubin (BIL) [mg/dL] measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in pH
Assessment of pH measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine erythrocytes and leukocytes
Assessment of erythrocytes (BLD), leukocytes (LEU) [cells/μL] measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine luteinizing hormone and nitrite
Assessment of luteinizing hormone (LH) and nitrite (NIT) [positive/negative] measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Measured: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 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, PhD, Study chair, Department of Sports Dietetics, Poznan University of Physical Education Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092930
- Sponsor's protocol ID
- ZDS2025_0001
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. De-identified individual participant data (IPD), including timepoint-specific values of primary and secondary outcome measures (e.g., performance results, hematological and physiological parameters), will be shared. Data will be made available upon reasonable request to qualified researchers for non-commercial academic purposes, following publication of the primary results. Requests should be directed to the corresponding author via institutional email. A data use agreement may be required.
Publications
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Jeukendrup AE, Vet-Joop K, Sturk A, Stegen JH, Senden J, Saris WH, Wagenmakers AJ. Relationship between gastro-intestinal complaints and endotoxaemia, cytokine release and the acute-phase reaction during and after a long-distance triathlon in highly trained men. Clin Sci (Lond). 2000 Jan;98(1):47-55.
PubMed 10600658
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Synergistic Effect of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Blood Biochemical Markers Concentrations in Trained Female Basketball Players
- ClinicalTrials.gov ID
- NCT07092930
- Acronym / sponsor ID
- ZDS2025_0001
- Conditions
- Supplementation, Sports, Female Athletes
- Keywords
- Beta-alanine, Sodium bicarbonate, Ergogenic aids, Sports nutrition, Team sports, Physical capacity, Body composition, Blood and urine biochemical markers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jul 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, parallel-group study aims to evaluate the potential synergistic effect of beta-alanine (BA) and sodium bicarbonate (SB) supplementation, compared to their separate administration or placebo (PL), on physical performance and selected blood biochemical markers in highly trained female basketball players.
Detailed description
Beta-alanine (BA) and sodium bicarbonate (SB) are commonly proposed as ergogenic aids due to their potential to enhance intracellular (BA) and extracellular (SB) buffering capacities, thereby improving physical performance. However, there is a lack of evidence regarding their potential synergistic effects, particularly in female athletes. Existing studies have primarily focused on male participants, despite emerging evidence suggesting sex-specific physiological responses to supplementation. Furthermore, research shows that females exhibit a high willingness to participate in scientific studies, underlining the importance of including female cohorts in sports supplementation research. To date, no randomized, double-blind, placebo-controlled trials have examined the combined and separate effects of BA and SB using a four-arm design (BA+SB, BA+PL2, PL1+SB, PL1+ PL2). Only one study to date has focused on chronic SB supplementation, whereas the majority have used acute protocols. Additionally, there is a notable lack of data on the use of BA and SB in team sports such as basketball, where repeated high-intensity efforts are dominant. Therefore, this study aims to investigate the chronic effects of BA and SB supplementation (administered individually or in combination) on physical capacity and selected blood biochemical markers in highly trained female basketball players, using a randomized, double-blind, placebo-controlled, parallel-group design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BA and SB supplementation (first group) | Experimental | Dietary Supplement: BA and SB supplementation |
| BA and PL2 supplementation (second group) | Experimental | Dietary Supplement: BA and PL2 supplementation |
| PL1 and SB supplementation (third group) | Experimental | Dietary Supplement: PL1 and SB supplementation |
| PL1 and PL2 supplementation (fourth group) | Placebo comparator | Dietary Supplement: PL1 and PL2 supplementation |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- written consent to participate,
- general good health condition,
- a current medical clearance to practice sports,
- training experience: at least 4 years,
- minimum of 4 workout sessions (in the discipline covered by the study) a week.
Key exclusion criteria (5 listed)
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- taking supplements, especially ergogenic supplements that modulate extra- and intracellular capacity 3 months prior to research (except taking protein and/or carbohydrate powders, isotonic drinks),
- 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 |
|---|---|---|
| BA and SB supplementationAssigned Interventions: * Beta-alanine (BA) * Sodium bicarbonate (SB) Description: • Participants receive beta-alanine and sodium bicarbonate Intervention list \& supplementation details: 1. Beta-alanine (BA) * Form: Gelatin capsules * Substance: Pure beta-alanine * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner) * Supplementation period: days 1 to 28 2. Sodium bicarbonate (SB) * Form: Gelatin capsules * Substance: Pure sodium bicarbonate * Daily dose: 0.3 g/kg body mass per day * Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner) * Supplementation period: days 21 to 28 of BA or PL1 supplementation Rationale: • This group tests the combined effects of BA and SB | Dietary supplement | BA and SB supplementation (first group) |
| BA and PL2 supplementationParticipants in this intervention group will undergo chronic supplementation with beta-alanine (BA) and an inert placebo (PL2) matched to the sodium bicarbonate (SB) protocol. * Beta-alanine (pure, in gelatin capsules) will be administered at a total daily dose of 6.4 g, divided into four servings taken with meals, over a period of 28 consecutive days. * PL2 (placebo matched to SB, in gelatin capsules) will be administered from Day 21 to Day 28 of beta-alanine supplementation, at a daily dose of 0.3 g per kg of body mass, divided into three equal servings taken with meals. This group allows for evaluation of the isolated effects of BA supplementation when combined with a placebo comparator to SB | Dietary supplement | BA and PL2 supplementation (second group) |
| PL1 and SB supplementationAssigned Interventions: * Placebo matched to BA (PL1) * Sodium bicarbonate (SB) Description: • Participants receive only sodium bicarbonate as the active compound and placebo capsules matching the BA protocol. Intervention list \& supplementation details: 1. Placebo matched to BA (PL1) * Form: Gelatin capsules * Substance: Inert substance matched in appearance and dosing schedule to BA * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner) * Supplementation period: days 1 to 28 2. Sodium bicarbonate (SB) * Form: Gelatin capsules * Substance: Pure sodium bicarbonate * Daily dose: 0.3 g/kg body mass per day * Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner) * Supplementation period: days 21 to 28 of BA or PL1 supplementation Rationale: • This group tests the isolated effects of SB | Dietary supplement | PL1 and SB supplementation (third group) |
| PL1 and PL2 supplementationAssigned Interventions: * Placebo matched to BA (PL1) * Placebo matched to SB (PL2) Description: • Participants receive two matched placebos. Intervention list \& supplementation details: 1. Placebo matched to BA (PL1) * Form: Gelatin capsules * Substance: Inert substance matched in appearance and dosing schedule to BA * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner) * Supplementation period: days 1 to 28 2. Placebo matched to SB (PL2) * Form: Gelatin capsules * Substance: Inert substance matched in appearance and timing to SB * Daily dose: 0.3 g/kg body mass per day * Dosing schedule: Three equal servings taken with meals (breakfast, lunch, dinner) * Supplementation period: days 21 to 28 of BA or PL1 supplementation Rationale: • This serves as the control group for comparison with all active intervention arms. | Dietary supplement | PL1 and PL2 supplementation (fourth group) |
Primary outcome
Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT)
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Assessment of peak power (PP), average power (AP), minimum power (MP), power drop (PD) [W (Watts)] using the Monark 894E ergometer (measured before and after incremental cycling test (ICT)) before and after supplementation (BA - beta-alanine; SB - sodium bicarbonate; PL - placebo; with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Changes in Countermovement Jump (CMJ) performance
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Assessment of three consecutive countermovement jump (CMJ) heights [cm (centimetres)] using the Microgate system, measured at rest and after the entire exercise procedure, both before and after supplementation.
Changes in aerobic capacity during incremental cycling test (ICT)
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Assessment of time to exhaustion [s (seconds)] during an incremental cycling test (ICT) using Ergoline E100P-K, measured before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Changes in blood bicarbonate, base excess, anion gap, and lactate concentrations
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Assessment of bicarbonate, base excess, anion gap, lactate [mmol/L] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
Changes in hydrogen ion concentration
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Assessment of hydrogen ion concentration [nmol/L] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).
25 secondary outcomes
Analysis of dietary energy intake
Time frame: 48 h before the first study visit and the second study visit after 28 days of intervention.
Analysis of dietary macronutrient intake
Time frame: 48 h before the first study visit and the second study visit after 28 days of intervention.
Changes in rate of perceived exertion
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in heart rate
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in gastrointestinal symptoms
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in body mass, fat-free mass and fat mass
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in total body water content
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in lymphocytes, monocytes, granulocytes, red blood cells and platelets
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in platelets distribution width and platelets large cell ratio
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in hemoglobin and mean corpuscular hemoglobin concentration
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in hematocrit
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in mean corpuscular volume, mean platelet volume, red blood cell distribution width
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in mean corpuscular hemoglobin
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in alanine aminotransferase, aspartate aminotransferase, creatine kinase and lactate dehydrogenase
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urea and magnesium
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in creatinine
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in iron and unsaturated iron binding capacity
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in transferrin
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in ferritin
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in potassium, sodium, ionized calcium, chloride, osmolality
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine specific gravity
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in protein, glucose, ketones, urobilinogen, bilirubin
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in pH
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine erythrocytes and leukocytes
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
Changes in urine luteinizing hormone and nitrite
Time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.
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 30 Jul 2025.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 10600658Jeukendrup AE, Vet-Joop K, Sturk A, Stegen JH, Senden J, Saris WH, Wagenmakers AJ. Relationship between gastro-intestinal complaints and endotoxaemia, cytokine release and the acute-phase reaction during and after a long-distance triathlon in highly trained men. Clin Sci (Lond). 2000 Jan;98(1):47-55.
- Individual participant dataSharing planned: Yes. 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. De-identified individual participant data (IPD), including timepoint-specific values of primary and secondary outcome measures (e.g., performance results, hematological and physiological parameters), will be shared. Data will be made available upon reasonable request to qualified researchers for non-commercial academic purposes, following publication of the primary results. Requests should be directed to the corresponding author via institutional email. A data use agreement may be required.
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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.
Krzysztof Durkalec-Michalski, PhD study chair
Department of Sports Dietetics, Poznan University of Physical Education Poznań
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 BA and SB supplementation, BA and PL2 supplementation and PL1 and SB supplementation in people with Supplementation and Sports, 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 5 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 30 Jul 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 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?
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 Jakub Adamczewski, MSc (+48 66 317 56 06, adamczewski@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT) (time frame: During the first study visit on the first day and during the second study visit after 28 days of intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092930, which also lists 2 linked publications.
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 30 Jul 2025.