Sodium Bicarbonate Supplementation in Combat Sports Athletes

Sponsor

Poznan University of Life Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03406065

Collaborator

Poznan University of PhysED (Other)

Enrollment

Location

Arms

5.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Oct 10, 2014

Actual Primary Completion Date :

Jan 20, 2015

Actual Study Completion Date :

Apr 5, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in anaerobic capacity after sodium bicarbonate supplementation [Baseline and after 10 days]
The Wingate Anaerobic Test (WAnT)
Changes in specific performance capacity after sodium bicarbonate supplementation [Baseline and after 10 days]
The wrestler's special endurance test - projective test with dummy (DT)

Secondary Outcome Measures

Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation [Baseline and after 10 days]
Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis
Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation [Baseline and after 10 days]
Creatine kinase [U/L] and lactate dehydrogenase [U/L] activity analysis
Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation [Baseline and after 10 days]
Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis
Changes in blood hematocrit levels after sodium bicarbonate supplementation [Baseline and after 10 days]
Hematocrit (HCT) [%] level analysis
Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation [Baseline and after 10 days]
Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis
Changes in polyphenols and albumin concentration [Baseline and after 10 days]
Polyphenols [g/L] and and albumin [g/L] concentration analysis
Changes in FRAP concentration [Baseline and after 10 days]
FRAP [µmol/L] concentration analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 30 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 PhysED

Investigators

Study Chair: Jan Jeszka, Professor, Poznan University of Life Sciences, ul. Wojska Polskiego 31, Poznań, Wielkopolska, Poland, 60-624

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poznan University of Life Sciences

ClinicalTrials.gov Identifier:

NCT03406065

Other Study ID Numbers:

ULS00003

First Posted:

Jan 23, 2018

Last Update Posted:

Jan 23, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Poznan University of Life Sciences

Study Results

No Results Posted as of Jan 23, 2018