Acute Sodium Bicarbonate Supplementation in Athletes

NCT ID: NCT03810404

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2025-01-20

Brief Summary

The purpose of this study is to verify the effect of acute sodium bicarbonate (SB) and placebo (PLA) supplementation on buffering potential kinetics, physical capacity, discipline-specific performance as well as concentration of diagnostically significant blood biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Detailed Description

Effective muscle work is conditioned by maintaining the proper range of muscles pH, regulated by buffering systems, in which the main role is played by bicarbonates (HCO3-). For this reason, sodium bicarbonate (SB) is often proposed as an ergogenic agent, especially during high-intensity efforts. Until now the major limitation to SB supplementation has been the gastrointestinal (GI) side effects. There is also a lack of data of the individual SB-induced changes of buffering potential kinetics and its actual connection with physical capacity and discipline-specific performance. Therefore, this study aims to examine the effect of acute, different-dose SB ingestion on buffering potential kinetics, physical capacity, discipline-specific performance as well as changes of diagnostically significant blood biochemical indices concentration in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Conditions

Supplementation; Sport

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sodium bicarbonate supplementation

Group taking oral SB supplementation in a different-dose regimen.

Group Type: EXPERIMENTAL

Sodium bicarbonate supplementation

Intervention Type: DIETARY_SUPPLEMENT

Interventions:

The experimental procedure for each athlete included an acute SB supplementation in a different-dose regimen in order to assess whether the dose affects the actual physical and exercise capacity (doses: 0.15-, 0.25-, 0.35- and 0.50 g/kgFFM (0.12-, 0.20-, 0.28- and 0.40 g/kgBM), respectively). SB (Alkala, SANUM, Poland) will be administered as dissolved form in a 750 ml of fluid (water + fruit juice). On testing days the SB will be taken before physical and exercise capacity tests session.

Between the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced.

Placebo treatment

Group taking oral supplementation with placebo (NaCl).

Group Type: PLACEBO_COMPARATOR

Placebo treatment

Intervention Type: DIETARY_SUPPLEMENT

Interventions:

The experimental procedure for each athlete will be included an PLA supplementation. Placebo will be administered in a form of 750 ml of fluid (water + fruit juice). On testing days the PLA will be taken before physical and exercise capacity tests session.

Between the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced.

Interventions

Sodium bicarbonate supplementation

Interventions:

The experimental procedure for each athlete included an acute SB supplementation in a different-dose regimen in order to assess whether the dose affects the actual physical and exercise capacity (doses: 0.15-, 0.25-, 0.35- and 0.50 g/kgFFM (0.12-, 0.20-, 0.28- and 0.40 g/kgBM), respectively). SB (Alkala, SANUM, Poland) will be administered as dissolved form in a 750 ml of fluid (water + fruit juice). On testing days the SB will be taken before physical and exercise capacity tests session.

Between the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced.

Intervention Type: DIETARY_SUPPLEMENT

Placebo treatment

Interventions:

The experimental procedure for each athlete will be included an PLA supplementation. Placebo will be administered in a form of 750 ml of fluid (water + fruit juice). On testing days the PLA will be taken before physical and exercise capacity tests session.

Between the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• written consent to participate,
• a current medical clearance to practice sports,
• training experience: at least 2 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,
• unwilling to follow the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Durkalec-Michalski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krzysztof Durkalec-Michalski, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Sports Dietetics, Poznan University of Physical Education

Locations

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, , Poland

Countries

Poland

Other Identifiers

ULS00006

Identifier Type: -

Identifier Source: org_study_id