Menu
Recruiting NCT07092930

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

Phase III Interventional Supplementation Sports Female Athletes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BA and SB supplementation, BA and PL2 supplementation, PL1 and SB supplementation, PL1 and PL2 supplementation.
Who it may be relevant to
Registry conditions: Supplementation, Sports, Female Athletes. Basic parameters: 16 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Dietary supplement BA and SB supplementation
    Assigned 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 *
  • Dietary supplement BA and PL2 supplementation
    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 o
  • Dietary supplement PL1 and SB supplementation
    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: 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, l
  • Dietary supplement PL1 and PL2 supplementation
    Assigned 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. Pl

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (12)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Department of Sports Dietetics, Poznan University of Physical Education Poznań — Poznan

Publications

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. PMID 7154893
  • Jeukendrup 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. PMID 10600658

Identifiers

NCT: NCT07092930 · ZDS2025_0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗