PerformanceNCT01621074
Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes
A study testing Sodium bicarbonate in people with Performance, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Performance
- What is being tested?
- Sodium bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
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.
- Conditions
- Performance
- Being tested
- Sodium bicarbonate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDietary supplement
Ergogenic effect
PlaceboDietary supplement
Placebo effect
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Active comparator | Not described Receives: Dietary Supplement: Sodium bicarbonate |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-exhaustion
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PerformanceStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Neurologie: Neurologische Forschung, Study director, University Hospital Zurich, Division of NeurologyMarco Toigo, PhD, Principal investigator, Swiss Federal Institute of Technology Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621074
- Sponsor's protocol ID
- nbc
- Status last verified
- Apr 2013
- First submitted
- 12 Jun 2012
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23531361
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes
- ClinicalTrials.gov ID
- NCT01621074
- Acronym / sponsor ID
- nbc
- Conditions
- Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Active comparator | Dietary Supplement: Sodium bicarbonate |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateErgogenic effect | Dietary supplement | Sodium bicarbonate |
| PlaceboPlacebo effect | Dietary supplement | Placebo |
Primary outcome
Time-to-exhaustion
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
- Derived from this study: PubMed 23531361Mueller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neurologie: Neurologische Forschung study director
University Hospital Zurich, Division of Neurology
Marco Toigo, PhD principal investigator
Swiss Federal Institute of Technology Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Performance, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-exhaustion (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.