NCT03165357

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

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, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2016

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

May 22, 2017

Last Update Submit

May 23, 2017

Conditions

SupplementationSport

Keywords

CrossfitSodium bicarbonatePhysical capacity

Outcome Measures

Primary Outcomes (2)

  • Changes in aerobic capacity after sodium bicarbonate supplementation

    The incremental cycling test (ICT)

    Baseline and after 10 days

  • 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 Outcomes (6)

  • Changes in fat mass and fat free mass 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

  • 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 lactate and pyruvate concentration in blood after sodium bicarbonate supplementation

    Baseline and after 10 days

  • +1 more secondary outcomes

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

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 (maltodextrin)

PLACEBO COMPARATOR

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

Interventions

Sodium bicarbonate supplementationDIETARY_SUPPLEMENT
Sodium bicarbonate
Placebo treatmentDIETARY_SUPPLEMENT
Placebo (maltodextrin)

Eligibility Criteria

Age20 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • years.

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

    Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

October 10, 2015

Primary Completion

March 10, 2016

Study Completion

April 5, 2016

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

PL(1)