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

NCT07092930 | Recruiting Phase 3

• 1 other identifier: ZDS2025_0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 trained female basketball players.

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

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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).

  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).

  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).

  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

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

• Analysis of dietary macronutrient intake

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

• Changes in rate of perceived exertion

  During the first study visit on the first day and during the second study visit after 28 days of intervention.

• Changes in heart rate

  During the first study visit on the first day and during the second study visit after 28 days of intervention.

• Changes in gastrointestinal symptoms

  During the first study visit on the first day and during the second study visit after 28 days of intervention.

Study Arms (4)

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

Interventions

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: 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

BA and SB supplementation (first group)

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

BA and PL2 supplementation (second group)

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: 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

PL1 and SB supplementation (third group)

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: 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.

PL1 and PL2 supplementation (fourth group)

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Department of Sports Dietetics, Poznan University of Physical Education Poznań

Poznan, Wielkopolska, 61-871, Poland

RECRUITING

Related Publications (2)

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

  PMID: 7154893 BACKGROUND

• 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 BACKGROUND

Study Officials

• Krzysztof Durkalec-Michalski, PhD

  Department of Sports Dietetics, Poznan University of Physical Education Poznań

  STUDY CHAIR

Central Study Contacts

Jakub Adamczewski, MSc

CONTACT

+48 66 317 56 06; adamczewski@awf.poznan.pl

Krzysztof Durkalec-Michalski, PhD

CONTACT

+48 61 835 51 65; durkalec-michalski@awf.poznan.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 30, 2025
• Study Start: October 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)