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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03165357
Other study ID # ULS00002
Secondary ID
Status Completed
Phase Phase 3
First received May 22, 2017
Last updated May 23, 2017
Start date October 10, 2015
Est. completion date April 5, 2016

Study information

Verified date May 2017
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 body composition, physical capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover 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, body composition and concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date April 5, 2016
Est. primary completion date March 10, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 43 Years
Eligibility Inclusion Criteria:

- written consent to participate,

- a current medical clearance to practice sports,

- training experience: at least 2 years (of CrossFit training),

- minimum of 3 workout sessions (CrossFit) a week,

- 20-43 years.

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

Placebo treatment


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 aerobic capacity after sodium bicarbonate supplementation The incremental cycling test (ICT) Baseline and after 10 days
Primary Changes in specific performance capacity after sodium bicarbonate supplementation The CrossFit-specific physical fitness test: Fight Gone Bad (FGB) Baseline and after 10 days
Secondary Changes in fat mass and fat free mass after sodium bicarbonate supplementation Fat mass (kg) and fat free mass (kg) 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 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 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
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