- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165357
Sodium Bicarbonate Supplementation in Athletes
The Effect of Sodium Bicarbonate Supplementation on Physical Capacity and Body Composition in Trained Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wielkopolska
-
Poznań, Wielkopolska, Poland, 60-624
- Poznan University of Life Sciences, ul.Wojska Polskiego 31
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- written consent to participate,
- a current medical clearance to practice sports,
- training experience: at least 2 years (of CrossFit training),
- minimum of 3 workout sessions (CrossFit) a week,
- 20-43 years.
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
Group taking oral NaHCO3 supplementation in a progressive-dose regimen. Interventions: The experimental procedure for each athlete included a 10-day NaHCO3 supplementation in a progressive-dose regimen in order to reduce the likelihood of gastrointestinal side effects (from 37.5 to 150 mg ∙ kg-1). NaHCO3 was administered in the form of unmarked disk-shaped tablets (Alkala T, SANUM, Poland). The tablets were ingested with at least 250 mL of water and could be either swallowed or dissolved in the mouth. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening. Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. |
|
Placebo Comparator: Placebo (maltodextrin)
Group taking oral supplementation with placebo (maltodextrin). Interventions: The experimental procedure for each athlete included a 10-day placebo administration. Placebo was ingested with at least 250 mL of water. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening. Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in aerobic capacity after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
The incremental cycling test (ICT)
|
Baseline and after 10 days
|
Changes in specific performance capacity after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
The CrossFit-specific physical fitness test: Fight Gone Bad (FGB)
|
Baseline and after 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in fat mass and fat free mass after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Fat mass (kg) and fat free mass (kg) analysis
|
Baseline and after 10 days
|
Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis
|
Baseline and after 10 days
|
Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis
|
Baseline and after 10 days
|
Changes in blood hematocrit levels after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Hematocrit (HCT) [%] level analysis
|
Baseline and after 10 days
|
Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis
|
Baseline and after 10 days
|
Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
Creatine kinase [U/L] and lactate dehydrogenase [U/L] activity analysis
|
Baseline and after 10 days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jan Jeszka, Professor, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ULS00002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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