Acute Sodium Bicarbonate Supplementation in Athletes

NCT03810404 | Active Not Recruiting Phase 3

• 1 other identifier: ULS00006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Supplementation; Sport

Keywords

Sports nutrition; Sodium bicarbonate; Physical capacity; Exercise performance; Buffering potential; Biochemical markers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Changes of pH in blood after sodium bicarbonate supplementation and placebo treatment

  Baseline and during 1 day of acute SB and PLA supplementation

• Changes of lactate concentration in blood after sodium bicarbonate supplementation and placebo treatment

  Baseline and during 1 day of acute SB and PLA supplementation

• Changes of pyruvate concentration in blood after sodium bicarbonate supplementation and placebo treatment

  Baseline and during 1 day of acute SB and PLA supplementation

• Changes in blood glucose concentration after sodium bicarbonate supplementation and placebo treatment

  Baseline and during 1 day of acute SB and PLA supplementation

• Changes in hemoglobin concentration after sodium bicarbonate supplementation and placebo treatment

  Baseline and during 1 day of acute SB and PLA supplementation

Study Arms (2)

Sodium bicarbonate supplementation

EXPERIMENTAL

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

Dietary Supplement: Sodium bicarbonate supplementation

Placebo treatment

PLACEBO COMPARATOR

Group taking oral supplementation with placebo (NaCl).

Dietary Supplement: Placebo treatment

Interventions

Sodium bicarbonate supplementation 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.

Sodium bicarbonate supplementation

Placebo treatment 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.

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• current injury,
• any health-related contraindication,
• declared general feeling of being unwell,
• unwilling to follow the study protocol.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, 61-871, Poland

Location

Study Officials

• Krzysztof Durkalec-Michalski, Prof., PhD

  Department of Sports Dietetics, Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: December 20, 2018
• Primary Completion: November 1, 2024
• Study Completion: January 20, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

PL (1)