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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03406065
Other study ID # ULS00003
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 14, 2018
Last updated January 14, 2018
Start date October 10, 2014
Est. completion date April 5, 2015

Study information

Verified date January 2018
Source Poznan University of Life Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 5, 2015
Est. primary completion date January 20, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
Poland Poznan University of Life Sciences, ul.Wojska Polskiego 31 Poznan Wielkopolska

Sponsors (2)

Lead Sponsor Collaborator
Poznan University of Life Sciences Department of Biochemistry, Poznan University of Physical Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in anaerobic capacity after sodium bicarbonate supplementation The Wingate Anaerobic Test (WAnT) Baseline and after 10 days
Primary 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 Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis Baseline and after 10 days
Secondary 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 Baseline and after 10 days
Secondary Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis Baseline and after 10 days
Secondary Changes in blood hematocrit levels after sodium bicarbonate supplementation Hematocrit (HCT) [%] level analysis Baseline and after 10 days
Secondary 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 Baseline and after 10 days
Secondary Changes in polyphenols and albumin concentration Polyphenols [g/L] and and albumin [g/L] concentration analysis Baseline and after 10 days
Secondary Changes in FRAP concentration FRAP [µmol/L] concentration analysis Baseline and after 10 days
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