- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810404
Acute Sodium Bicarbonate Supplementation in Athletes
The Effect of Acute Sodium Bicarbonate Supplementation on Buffering Potential Kinetics, Physical Capacity and Discipline-Specific Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Poznań, Poland, 61-871
- Department of Sports Dietetics, Poznan University of Physical Education
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sodium bicarbonate supplementation
Group taking oral SB supplementation in a different-dose regimen.
|
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 Comparator: Placebo treatment
Group taking oral supplementation with placebo (NaCl).
|
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. |
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
Time Frame: Baseline and during 1 day of acute SB and PLA supplementation
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Krzysztof Durkalec-Michalski, Prof., PhD, Department of Sports Dietetics, Poznan University of Physical Education
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ULS00006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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