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

NCT ID: NCT07092930

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Supplementation Sports Female Athletes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BA and SB supplementation (first group)

Group Type EXPERIMENTAL

BA and SB supplementation

Intervention Type 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 PL2 supplementation (second group)

Group Type EXPERIMENTAL

BA and PL2 supplementation

Intervention Type 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 (third group)

Group Type EXPERIMENTAL

PL1 and SB supplementation

Intervention Type 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 PL2 supplementation (fourth group)

Group Type PLACEBO_COMPARATOR

PL1 and PL2 supplementation

Intervention Type 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.

Interventions

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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
* 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

Intervention Type 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 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

Intervention Type 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, 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

Intervention Type 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. 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Krzysztof Durkalec-Michalski

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krzysztof Durkalec-Michalski, PhD

Role: STUDY_CHAIR

Department of Sports Dietetics, Poznan University of Physical Education Poznań

Locations

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Department of Sports Dietetics, Poznan University of Physical Education Poznań

Poznan, Wielkopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jakub Adamczewski, MSc

Role: CONTACT

+48 66 317 56 06

Krzysztof Durkalec-Michalski, PhD

Role: CONTACT

+48 61 835 51 65

Facility Contacts

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Jakub Adamczewski, MSc

Role: primary

+48 66 317 56 06

Krzysztof Durkalec-Michalski, PhD

Role: backup

+48 61 835 51 65

References

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

Reference Type BACKGROUND
PMID: 7154893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10600658 (View on PubMed)

Other Identifiers

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ZDS2025_0001

Identifier Type: -

Identifier Source: org_study_id

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