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CompletedNCT03406065Updated Jan 23, 2018

Sodium Bicarbonate Supplementation in Combat Sports Athletes

A Phase 2/3 interventional study of Sodium bicarbonate supplementation and Placebo treatment in Supplementation and Sport, sponsored by Poznan University of Life Sciences. Completed at 1 site in Poland. Open to participants aged 17 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Poznan University of Life Sciences · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
17 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Supplementation
  • Sport

Keywords

  • Sodium bicarbonate
  • NaHCO3
  • Combat Sports
  • Physical capacity
  • Dummy test
03

Who can participate

Ages eligible
17 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • current injury,
  • any health-related contraindication,
  • declared general feeling of being unwell,
  • unwilling to follow the study protocol.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Sodium bicarbonate supplementation

    Group taking oral NaHCO3 supplementation in a progressive-dose regimen.

    Dietary Supplement: Sodium bicarbonate supplementation

  • 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

Interventions

  • Dietary supplementSodium 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.

  • Dietary supplementPlacebo 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.

05

What researchers measure

Primary outcomes

  1. Changes in anaerobic capacity after sodium bicarbonate supplementation

    The Wingate Anaerobic Test (WAnT)

    Time frame: Baseline and after 10 days

  2. Changes in specific performance capacity after sodium bicarbonate supplementation

    The wrestler's special endurance test - projective test with dummy (DT)

    Time frame: Baseline and after 10 days

Secondary outcomes

  1. Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation

    Lactate \[mmol/L\] and pyruvate \[mmol/L\] concentration analysis

    Time frame: Baseline and after 10 days

  2. Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation

    Creatine kinase \[U/L\] and lactate dehydrogenase \[U/L\] activity analysis

    Time frame: Baseline and after 10 days

  3. Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation

    Hemoglobin (Hb) \[g/dl\] and glucose \[g/dl\] concentration analysis

    Time frame: Baseline and after 10 days

  4. Changes in blood hematocrit levels after sodium bicarbonate supplementation

    Hematocrit (HCT) \[%\] level analysis

    Time frame: Baseline and after 10 days

  5. Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation

    Red blood cells (RBC) \[mln/mm³\] and white blood cells (WBC) \[mln/mm³\] concentration analysis

    Time frame: Baseline and after 10 days

  6. Changes in polyphenols and albumin concentration

    Polyphenols \[g/L\] and and albumin \[g/L\] concentration analysis

    Time frame: Baseline and after 10 days

  7. Changes in FRAP concentration

    FRAP \[µmol/L\] concentration analysis

    Time frame: Baseline and after 10 days

06

Study locations

1 site
  • Poznan University of Life Sciences, ul.Wojska Polskiego 31
    Poznań, Wielkopolska 60-624, Poland
07

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406065
Lead sponsor
Poznan University of Life Sciences
Collaborators
Poznan University of PhysED
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Oct 10, 2014
Primary completion
Jan 20, 2015
Completion
Apr 5, 2015
Last update
Jan 23, 2018

Study contacts

Jan Jeszka, Professor
study chair · Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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