NCT03406065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 14, 2018

Last Update Submit

January 14, 2018

Conditions

SupplementationSport

Keywords

Sodium bicarbonateNaHCO3Combat SportsPhysical capacityDummy test

Outcome Measures

Primary Outcomes (2)

  • Changes in anaerobic capacity after sodium bicarbonate supplementation

    The Wingate Anaerobic Test (WAnT)

    Baseline and after 10 days

  • Changes in specific performance capacity after sodium bicarbonate supplementation

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

    Baseline and after 10 days

Secondary Outcomes (7)

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

    Baseline and after 10 days

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

    Baseline and after 10 days

  • Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation

    Baseline and after 10 days

  • Changes in blood hematocrit levels after sodium bicarbonate supplementation

    Baseline and after 10 days

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

    Baseline and after 10 days

  • +2 more secondary outcomes

Study Arms (2)

Sodium bicarbonate supplementation

EXPERIMENTAL

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

Dietary Supplement: Sodium bicarbonate supplementation

Placebo treatment

PLACEBO COMPARATOR

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

Sodium bicarbonate supplementationDIETARY_SUPPLEMENT

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.

Sodium bicarbonate supplementation
Placebo treatmentDIETARY_SUPPLEMENT

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.

Placebo treatment

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Life Sciences, ul.Wojska Polskiego 31

Poznan, Wielkopolska, 60-624, Poland

Location

Study Officials

  • Jan Jeszka, Professor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2018

First Posted

January 23, 2018

Study Start

October 10, 2014

Primary Completion

January 20, 2015

Study Completion

April 5, 2015

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

PL(1)