- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01621074
Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes
April 11, 2013 updated by: University of Zurich
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Neurology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo effect
|
ACTIVE_COMPARATOR: Sodium bicarbonate
|
Ergogenic effect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-to-exhaustion
Time Frame: 5 weeks
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Neurologie: Neurologische Forschung, University Hospital Zurich, Division of Neurology
- Principal Investigator: Marco Toigo, PhD, Swiss Federal Institute of Technology Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
June 12, 2012
First Submitted That Met QC Criteria
June 14, 2012
First Posted (ESTIMATE)
June 15, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 12, 2013
Last Update Submitted That Met QC Criteria
April 11, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- nbc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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