NCT01621074

Brief Summary

During endurance exercise in the heavy and severe intensity domains, the rate at which metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium bicarbonate, as a nutritional supplement, has gained attention over the past decades, because it might delay of offset fatigue. To date, there is a controversial discussion about which delivery mode (amount and frequency) might be best in optimizing endurance performance. Since the high ion load consequent to multiple ingestions might increase plasma volume, and consequently decrease bicarbonate concentrations, single acute ingestion could be more beneficial. However, in multi-day competitions or tournaments it might be necessary to use the supplement on a daily basis. Here, the investigators aim at investigating the effects of single dose or multiple dose (on five consecutive days) administration of bicarbonate vs. placebo increases endurance performance and acid-base homeostasis in trained male endurance athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

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

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

June 12, 2012

Last Update Submit

April 11, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time-to-exhaustion

    5 weeks

Study Arms (2)

Sodium bicarbonate

ACTIVE COMPARATOR
Dietary Supplement: Sodium bicarbonate

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Sodium bicarbonateDIETARY_SUPPLEMENT

Ergogenic effect

Sodium bicarbonate
PlaceboDIETARY_SUPPLEMENT

Placebo effect

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • no cold or temperature at beginning or during the study
  • between 18 and 45 years of age
  • active in endurance sports (3 to 5 times per week a moderate to hart training)
  • non-smoker
  • no known cardiovascular or orthopedic problems
  • no known limitations of kidney function
  • no bearer of a cardiac pacemaker
  • no medications with direct influence on the measurements. The whole intake of medicaments has to be declared in the health questionnaire by the participant.
  • requirements of the health questionnaire fulfilled

You may not qualify if:

  • male and age under 18 or over 45 years
  • cold or temperature at the beginning or during the study
  • untrained (less than 3 moderate trainings per week)
  • smoker
  • cardiovascular or orthopedic problems
  • limitations of the kidney function
  • bearer of a cardiac pacemaker
  • medication with direct influence on the measurements. The whole intake of medicaments has to be declared in the health questionnaire by the participant.
  • requirements of the health questionnaire not fulfilled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Mueller SM, Gehrig SM, Frese S, Wagner CA, Boutellier U, Toigo M. Multiday acute sodium bicarbonate intake improves endurance capacity and reduces acidosis in men. J Int Soc Sports Nutr. 2013 Mar 26;10(1):16. doi: 10.1186/1550-2783-10-16.

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Neurologie: Neurologische Forschung

    University Hospital Zurich, Division of Neurology

    STUDY DIRECTOR
  • Marco Toigo, PhD

    Swiss Federal Institute of Technology Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

October 1, 2011

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations