Acute Sodium Bicarbonate Supplementation in Athletes

Study Overview
=================
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.

Official Title
-----------------
The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance

Conditions
-----------------
Supplementation, Sport

Intervention / Treatment
-----------------
* Dietary Supplement: Sodium bicarbonate supplementation
* Dietary Supplement: Placebo treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate supplementation<br>Group taking oral SB supplementation in a different-dose regimen. | Dietary Supplement: Sodium bicarbonate supplementation<br>* 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.<br>|
| Placebo Comparator: Placebo treatment<br>Group taking oral supplementation with placebo (NaCl). | Dietary Supplement: Placebo treatment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sports nutrition, Sodium bicarbonate, Physical capacity, Exercise performance, Buffering potential, Biochemical markers