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NCT Number: NCT07092930

Effects of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Biochemical Markers Concentrations

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.

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Key information

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

BA and SB supplementation

Dietary 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 supplementation

Dietary 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 supplementation

Dietary 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 supplementation

Dietary 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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. Analysis of dietary energy intake

    Time frame: 48 h before the first study visit and the second study visit after 28 days of intervention.

    Assessment of energy intake [kcal (kilocalories)], before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

  2. Analysis of dietary macronutrient intake

    Time frame: 48 h before the first study visit and the second study visit after 28 days of intervention.

    Assessment of macronutrients intake (proteins, carbohydrates, fats) [g (grams)], before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

  3. 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.

    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).

  4. 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.

    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).

  5. 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.

    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).

  6. 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.

    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).

  7. 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.

    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).

  8. 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.

    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).

  9. 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.

    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).

  10. 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.

    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).

  11. 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.

    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).

  12. 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.

    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).

  13. 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.

    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).

  14. 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.

    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).

  15. 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.

    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).

  16. 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.

    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).

  17. 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.

    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)

  18. 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.

    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).

  19. 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.

    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).

  20. 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.

    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).

  21. 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.

    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

  22. 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.

    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).

  23. 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.

    Assessment of pH measured in urine at rest, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

  24. 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.

    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).

  25. 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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jakub Adamczewski, MSc

CONTACT

[email protected]

+48 66 317 56 06

Krzysztof Durkalec-Michalski, PhD

CONTACT

[email protected]

+48 61 835 51 65

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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