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Sodium Bicarbonate Supplementation in Combat Sports Athletes

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ClinicalTrials.gov Identifier: NCT03406065
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Poznan University of Physical Education
Information provided by (Responsible Party):
Poznan University of Life Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Supplementation Sport Dietary Supplement: Sodium bicarbonate supplementation Dietary Supplement: Placebo treatment Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sodium Bicarbonate Supplementation on Physical and Specific Performance Capacity in Combat Sports Athletes
Actual Study Start Date : October 10, 2014
Actual Primary Completion Date : January 20, 2015
Actual Study Completion Date : April 5, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium bicarbonate supplementation
Group taking oral NaHCO3 supplementation in a progressive-dose regimen.
Dietary Supplement: Sodium bicarbonate supplementation
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.
Dietary Supplement: Placebo treatment
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.




Primary Outcome Measures :
  1. Changes in anaerobic capacity after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    The Wingate Anaerobic Test (WAnT)

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Changes in blood hematocrit levels after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Hematocrit (HCT) [%] level analysis

  5. 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

  6. Changes in polyphenols and albumin concentration [ Time Frame: Baseline and after 10 days ]
    Polyphenols [g/L] and and albumin [g/L] concentration analysis

  7. Changes in FRAP concentration [ Time Frame: Baseline and after 10 days ]
    FRAP [µmol/L] concentration analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406065


Locations
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Poland
Poznan University of Life Sciences, ul.Wojska Polskiego 31
Poznań, Wielkopolska, Poland, 60-624
Sponsors and Collaborators
Poznan University of Life Sciences
Poznan University of Physical Education
Investigators
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Study Chair: Jan Jeszka, Professor Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624

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Responsible Party: Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03406065     History of Changes
Other Study ID Numbers: ULS00003
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poznan University of Life Sciences:
Sodium bicarbonate
NaHCO3
Combat Sports
Physical capacity
Dummy test