NCT01835912

Brief Summary

Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing \[H+\] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 24, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

April 10, 2013

Results QC Date

March 19, 2014

Last Update Submit

July 23, 2014

Conditions

Alkalosis

Keywords

performancespeedexertion

Outcome Measures

Primary Outcomes (1)

  • Time

    time to complete 200 metre swimming performances in seconds Participants chose type of swim stroke to swim a maximal effort 200 metre performance

    once each 200m performance

Secondary Outcomes (1)

  • Lactate

    3 min post performance

Other Outcomes (1)

  • Rate of Perceived Exertion

    Rate of Perceived Exertion after each 200m swimming performance

Study Arms (4)

Flavoured water placebo for acute dosing

PLACEBO COMPARATOR

500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)

Other: Sodium Citrate Dihydrate

Sodium Citrate Dihydrate Acute

EXPERIMENTAL

dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water

Other: Sodium Citrate Dihydrate

Flavoured water placebo chronic dosing

PLACEBO COMPARATOR

500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)

Other: Sodium Citrate Dihydrate

Sodium Citrate Dihydrate Chronic

EXPERIMENTAL

3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water

Other: Sodium Citrate Dihydrate

Interventions

Sodium Citrate DihydrateOTHER

Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)

Also known as: CAS: 6132-04-3
Flavoured water placebo chronic dosingFlavoured water placebo for acute dosingSodium Citrate Dihydrate AcuteSodium Citrate Dihydrate Chronic

Eligibility Criteria

Age13 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 13-17
  • Male
  • Regional, provincial and national level swimmers

You may not qualify if:

  • Females
  • Level of swimming below regional level standards
  • Caffeine before trials
  • Chronic health concerns
  • Health problems before or during the course of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, l2s3a1, Canada

Location

Related Publications (1)

  • Russell C, Papadopoulos E, Mezil Y, Wells GD, Plyley MJ, Greenway M, Klentrou P. Acute versus chronic supplementation of sodium citrate on 200 m performance in adolescent swimmers. J Int Soc Sports Nutr. 2014 Jun 12;11:26. doi: 10.1186/1550-2783-11-26. eCollection 2014.

    PMID: 24944546DERIVED

MeSH Terms

Conditions

Alkalosis

Interventions

Sodium Citrate

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Citric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Panagiota Klentrou
Organization
BrockU
nklentrou@brocku.ca
19056885550

Study Officials

  • Nota Klentrou, PhD

    Brock University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc. Researcher Brock University

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 19, 2013

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

July 24, 2014

Results First Posted

July 24, 2014

Record last verified: 2014-07

Locations

CA(1)