NCT07017582

Brief Summary

The objetive of the study was to determine whether sodium bicarbonate supplementation improves athletic performance and/or reduces fatigue in elite rugby players. The participants were 17 elite rugby players. Half of the participants receive sodium bicarbonate (0.3 g/kg body weight), the other half receive a placebo (salt). Ingestion of the supplementation/placebo occured 90 minutes before high-intensity rugby-specific training Variables analysed were measure at baseline, prior to exercise, during exercise and after exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

13 days

First QC Date

May 23, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

BicarbonateRugbyPerformance

Outcome Measures

Primary Outcomes (1)

  • Capillary blood lactate

    Lactate concentrations were measured in a capillary blood sample obtained fromparticipants' fingertips using a portable analyzer (Lactate 2, Arkray, Kyoto, Japan)

    At baseline (prior to supplementation), prior to exercise (immediately before beginning exercise protocol), after exercise (immediately after finishing exercise protocol).

Secondary Outcomes (2)

  • Countermovement jump

    At baseline (prior to supplementation) and after exercise (immediately after finishing exercise protocol).

  • Gastrointestinal (GI) symptoms

    At baseline (before supplementation), prior to exercise (immediately before beginning exercise protocol), after exercise (immediately after finishing exercise protocol).

Study Arms (2)

Bicarbonate

ACTIVE COMPARATOR

Supplementation with 0.3 g/kg of sodium bicarbonate

Dietary Supplement: Soidum Bicarbonate

Placebo

PLACEBO COMPARATOR

Supplementation with placebo: 0.03 g·kg-1 body mass sodium chloride

Dietary Supplement: Placebo

Interventions

Soidum BicarbonateDIETARY_SUPPLEMENT

Supplementation with 0.03 g/kg of sodium bicarbonate

Bicarbonate
PlaceboDIETARY_SUPPLEMENT

0.03 g·kg-1 body mass sodium chloride

Placebo

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male rugby players who were competing in the First Spanish National League (Division de Honor A) voluntarily agreed to participate in the study after attending an informative session

You may not qualify if:

  • injury or illness on test day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Burgos

Burgos, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 12, 2025

Study Start

February 1, 2023

Primary Completion

February 14, 2023

Study Completion

February 15, 2023

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Confidential data regarding a rugby club

Locations