Department of Sports Dietetics, Poznan University of Physical Education Poznań
Poznan, Wielkopolska, 61-871, Poland
Location status: Recruiting
Location contact
Jakub Adamczewski, MSc
CONTACT
Krzysztof Durkalec-Michalski, PhD
CONTACT
NCT Number: NCT07092930
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.
Interested in participating?
Request Info16 year–40 year
Female
Interventional
Phase 3
Poznan, Wielkopolska, 61-871, Poland
Location status: Recruiting
Jakub Adamczewski, MSc
CONTACT
Krzysztof Durkalec-Michalski, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assigned Interventions:
Description:
Intervention list & supplementation details:
Rationale:
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.
This group allows for evaluation of the isolated effects of BA supplementation when combined with a placebo comparator to SB
Assigned Interventions:
Description:
Intervention list & supplementation details:
Rationale:
Assigned Interventions:
Description:
Intervention list & supplementation details:
Rationale:
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).
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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)
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).
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).
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).
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
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).
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).
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).
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).
Contact information is provided by the study sponsor or research team.
Jakub Adamczewski, MSc
CONTACT
Krzysztof Durkalec-Michalski, PhD
CONTACT
Poznan University of Physical Education
Other
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
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