Sports Nutritional Physiological PhenomenaNCT02474628
Consistencies in Responses to Sodium Bicarbonate?
A study testing sodium bicarbonate and calcium carbonate in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutritional Physiological Phenomena
- What is being tested?
- sodium bicarbonate and calcium carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Jun 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- recreationally active males
Who cannot join
- use of dietary supplements in the past 6 months
- the presence of any musculoskeletal disorder
- the use of anabolic steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consistencies in Responses to Sodium Bicarbonate Supplementation: a Randomised, Repeated Measures, Counterbalanced and Double-blind Study
Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.
- Being tested
- sodium bicarbonate, calcium carbonate
- Keywords
- Physiological Phenomena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDietary supplement
calcium carbonateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.3 g∙kg-1body mass of calcium carbonate Receives: Dietary Supplement: calcium carbonate |
| Sodium bicarbonate | Experimental | 0.3 g∙kg-1body mass of sodium bicarbonate Receives: Dietary Supplement: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pH
Measured: 5 min after a physical exercise test
Secondary outcomes (3)
blood bicarbonate
Measured: 5 min after a physical exercise test
blood lactate
Measured: 5 min after a physical exercise test
anaerobic exercise capacity
as assessed by cycling capacity tests at 110% of maximum power output
Measured: 4 hours after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Sports Nutritional Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474628
- Sponsor's protocol ID
- Sodium bicarbonate consistency
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Froio de Araujo Dias G, da Eira Silva V, de Salles Painelli V, Sale C, Giannini Artioli G, Gualano B, Saunders B. (In)Consistencies in Responses to Sodium Bicarbonate Supplementation: A Randomised, Repeated Measures, Counterbalanced and Double-Blind Study. PLoS One. 2015 Nov 17;10(11):e0143086. doi: 10.1371/journal.pone.0143086. eCollection 2015.
PubMed 26574755
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistencies in Responses to Sodium Bicarbonate Supplementation: a Randomised, Repeated Measures, Counterbalanced and Double-blind Study
- ClinicalTrials.gov ID
- NCT02474628
- Acronym / sponsor ID
- Sodium bicarbonate consistency
- Keywords
- Physiological Phenomena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jun 2015 (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.
Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: calcium carbonate0.3 g∙kg-1body mass of calcium carbonate |
| Sodium bicarbonate | Experimental | Dietary Supplement: sodium bicarbonate0.3 g∙kg-1body mass of sodium bicarbonate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- recreationally active males
Key exclusion criteria (3 listed)
- use of dietary supplements in the past 6 months
- the presence of any musculoskeletal disorder
- the use of anabolic steroids
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 bicarbonate | Dietary supplement | Sodium bicarbonate |
| calcium carbonate | Dietary supplement | Placebo |
Primary outcome
blood pH
Time frame: 5 min after a physical exercise test
3 secondary outcomes
blood bicarbonate
Time frame: 5 min after a physical exercise test
blood lactate
Time frame: 5 min after a physical exercise test
anaerobic exercise capacity
Time frame: 4 hours after supplementation
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 18 Jun 2015.
- Derived from this study: PubMed 26574755Froio de Araujo Dias G, da Eira Silva V, de Salles Painelli V, Sale C, Giannini Artioli G, Gualano B, Saunders B. (In)Consistencies in Responses to Sodium Bicarbonate Supplementation: A Randomised, Repeated Measures, Counterbalanced and Double-Blind Study. PLoS One. 2015 Nov 17;10(11):e0143086. doi: 10.1371/journal.pone.0143086. eCollection 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and calcium carbonate in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 3 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 18 Jun 2015. 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 Brazil. 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?
blood pH (time frame: 5 min after a physical exercise test). 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 NCT02474628, 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 18 Jun 2015.