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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03810404
Other study ID # ULS00006
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 20, 2018
Est. completion date January 20, 2025

Study information

Verified date May 2024
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date January 20, 2025
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.
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.

Locations

Country Name City State
Poland Department of Sports Dietetics, Poznan University of Physical Education Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in anaerobic capacity after sodium bicarbonate supplementation and placebo treatment The Wingate cycling test carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Primary Changes in discipline-specific exercise capacity after sodium bicarbonate supplementation and placebo treatment The discipline-specific exercise capacity tests carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Primary Changes of bicarbonate concentration in blood after sodium bicarbonate supplementation and placebo treatment Bicarbonate (HCO3-) [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Primary Changes of base excess concentration in blood after sodium bicarbonate supplementation and placebo treatment Base excess [mmol/L] concentration analysis in blood carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment Blood pH (pH units) analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment Lactate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment Pyruvate [mmol/L] concentration analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment Glucose [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment Hemoglobin (Hb) [g/dl] concentration analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of blood cells concentration in blood after sodium bicarbonate supplementation and placebo treatment Blood cells [mln/mm³] concentration analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of creatine kinase activity in blood after sodium bicarbonate supplementation and placebo treatment Creatine kinase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
Secondary Changes of lactate dehydrogenase activity in blood after sodium bicarbonate supplementation and placebo treatment Lactate dehydrogenase [U/L] activity analysis carried out at baseline, and after SB and PLA supplementation Baseline and during 1 day of acute SB and PLA supplementation
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