- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406065
Sodium Bicarbonate Supplementation in Combat Sports Athletes
January 14, 2018 updated by: Poznan University of Life Sciences
The Effect of Sodium Bicarbonate Supplementation on Physical and Specific Performance Capacity in Combat Sports Athletes
The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and placebo (PLA) supplementation on physical and specific performance capacity, as well as concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves high-intensity and resistance exercise performance.
Until now the major limitation to NaHCO3 supplementation has been the gastrointestinal (GI) side effects.
Therefore, this study aims to examine the effect of chronic, progressive-dose NaHCO3 ingestion on physical capacity and specific performance capacity, and concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wielkopolska
-
Poznań, Wielkopolska, Poland, 60-624
- Poznan University of Life Sciences, ul.Wojska Polskiego 31
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- written informed consent from all participants before the study (included aslo informed consents to the participation in the study of athletes under the age of 18 obtained from their parents)
- a current medical clearance to practice sports,
- training experience: at least 4 years (of combat sport training),
- minimum of 4 workout sessions (combat sport) a week,
Exclusion Criteria:
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium bicarbonate supplementation
Group taking oral NaHCO3 supplementation in a progressive-dose regimen.
|
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 25 to 100 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.
|
Placebo Comparator: Placebo treatment
Group taking oral supplementation with placebo (maltodextrin with NaCl) in a similar tablet form prepared by the same producer as NaHCO3 tablets.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in anaerobic capacity after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
The Wingate Anaerobic Test (WAnT)
|
Baseline and after 10 days
|
Changes in specific performance capacity after sodium bicarbonate supplementation
Time Frame: Baseline and after 10 days
|
The wrestler's special endurance test - projective test with dummy (DT)
|
Baseline and after 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes in polyphenols and albumin concentration
Time Frame: Baseline and after 10 days
|
Polyphenols [g/L] and and albumin [g/L] concentration analysis
|
Baseline and after 10 days
|
Changes in FRAP concentration
Time Frame: Baseline and after 10 days
|
FRAP [µmol/L] concentration analysis
|
Baseline and after 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jan Jeszka, Professor, Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2014
Primary Completion (Actual)
January 20, 2015
Study Completion (Actual)
April 5, 2015
Study Registration Dates
First Submitted
January 14, 2018
First Submitted That Met QC Criteria
January 14, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Actual)
January 23, 2018
Last Update Submitted That Met QC Criteria
January 14, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- ULS00003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Shared data will be exclusively related to the level recorded indicators (anaerobic capacity and specific performance capacity indicators, levels of biochemical markers, body composition), without personal data.
The data obtained will be attached to scientific publications, depending on the requirements of the journal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Supplementation
-
Universidad Católica San Antonio de MurciaCompleted
-
California Baptist UniversityCompletedDietary SupplementationUnited States
-
Poznan University of Life SciencesNational Science Centre, PolandUnknown
-
Texas A&M UniversityNutrition 21, Inc.Completed
-
University of AarhusCompleted
-
Texas A&M UniversityNutraboltCompletedDietary Supplementation
-
Eisenhower Army Medical CenterMedical Nutrition USA, Inc.CompletedProtein Supplementation
-
Alexandria UniversityRecruitingProtein SupplementationEgypt
-
Poznan University of Physical EducationPoznan University of Life SciencesCompletedSupplementation | SportsPoland
-
Bettery S.A.CompletedProtein SupplementationPortugal
Clinical Trials on Sodium bicarbonate supplementation
-
Poznan University of Life SciencesPoznan University of PhysEDCompleted
-
Poznan University of Physical EducationActive, not recruiting
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)CompletedChronic Kidney Disease | DisabilityUnited States
-
Sheba Medical CenterUnknownExtravasation | InfiltrationIsrael
-
GlaxoSmithKlineCompleted
-
Guy's and St Thomas' NHS Foundation TrustUniversity of PittsburghNot yet recruitingCovid19 | Acute Kidney Injury
-
Prim. Priv. Doz. Dr. Daniel CejkaMedice Arzneimittel Pütter GmbH & Co KGWithdrawnKidney Transplant; ComplicationsAustria
-
Jennifer Gassman, PhDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The...CompletedChronic Kidney DiseaseUnited States
-
Lars Wiuff AndersenUniversity of AarhusRecruiting
-
University of UtahThe University of Utah Center on AgingTerminatedChronic Kidney DiseaseUnited States