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Sodium Bicarbonate Supplementation in Athletes

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ClinicalTrials.gov Identifier: NCT03165357
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Poznan University of Physical Education
Information provided by (Responsible Party):
Poznan University of Life Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Supplementation Sport Dietary Supplement: Sodium bicarbonate supplementation Dietary Supplement: Placebo treatment 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, body composition and concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sodium Bicarbonate Supplementation on Physical Capacity and Body Composition in Trained Athletes
Actual Study Start Date : October 10, 2015
Actual Primary Completion Date : March 10, 2016
Actual Study Completion Date : April 5, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium bicarbonate

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

Interventions:

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 37.5 to 150 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.

Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced.

Dietary Supplement: Sodium bicarbonate supplementation
Placebo Comparator: Placebo (maltodextrin)

Group taking oral supplementation with placebo (maltodextrin).

Interventions:

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.

Between the 10-day NaHCO3 and PLA or a PLA and NaHCO3 treatments, a 14-day washout period was introduced.

Dietary Supplement: Placebo treatment



Primary Outcome Measures :
  1. Changes in aerobic capacity after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    The incremental cycling test (ICT)

  2. Changes in specific performance capacity after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    The CrossFit-specific physical fitness test: Fight Gone Bad (FGB)


Secondary Outcome Measures :
  1. Changes in fat mass and fat free mass after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Fat mass (kg) and fat free mass (kg) analysis

  2. Changes of red and white blood cell concentration in blood after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis

  3. Changes in blood glucose and hemoglobin concentration after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis

  4. Changes in blood hematocrit levels after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Hematocrit (HCT) [%] level analysis

  5. Changes of lactate and pyruvate concentration in blood after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Lactate [mmol/L] and pyruvate [mmol/L] concentration analysis

  6. Changes of creatine kinase and lactate dehydrogenase activity in blood after sodium bicarbonate supplementation [ Time Frame: Baseline and after 10 days ]
    Creatine kinase [U/L] and lactate dehydrogenase [U/L] activity analysis



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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165357


Locations
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Poland
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 Physical Education
Investigators
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Study Chair: Jan Jeszka, Professor Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland

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Responsible Party: Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03165357     History of Changes
Other Study ID Numbers: ULS00002
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Shared data will be exclusively related to the level recorded indicators (body composition, aerobic and anaerobic capacity indicators, levels of biochemical markers), without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal
Keywords provided by Poznan University of Life Sciences:
Crossfit
Sodium bicarbonate
Physical capacity