Influence of Sodium Bicarbonate on Time-to-exhaustion at... | NCT01621074

Studies
Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes

NCT01621074

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Apr 12, 2013Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Performance

Interventions

Sodium bicarbonate
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 14, 2012

First Posted Date

Jun 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2013

Last Update Posted Date

Apr 12, 2013Estimated

Name	Class
Swiss Federal Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium bicarbonate	Active Comparator		Dietary Supplement: Sodium bicarbonate
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium bicarbonate	Dietary Supplement	Ergogenic effect	Sodium bicarbonate

Measure	Description	Time Frame
Time-to-exhaustion		5 weeks

Eligibility Module

Eligibility Criteria

Inclusion criteria: - male

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

Exclusion criteria: - female

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neurologie: Neurologische Forschung	University Hospital Zurich, Division of Neurology	Study Director
Marco Toigo, PhD	Swiss Federal Institute of Technology Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Neurology		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23531361	Derived	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.

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic