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
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Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2023-10-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BA and SB supplementation (first group)
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
BA and PL2 supplementation (second group)
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
PL1 and SB supplementation (third group)
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
PL1 and PL2 supplementation (fourth group)
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.
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
40 Years
FEMALE
Yes
Sponsors
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Poznan University of Physical Education
OTHER
Responsible Party
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Krzysztof Durkalec-Michalski
Prof.
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
Countries
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Central Contacts
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Facility Contacts
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References
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Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
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.
Other Identifiers
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ZDS2025_0001
Identifier Type: -
Identifier Source: org_study_id
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