Sports Nutritional Physiological PhenomenaNCT03505970
Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation
A study testing Sodium bicarbonate and Maltodextrin in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo.
Trial summary
The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutritional Physiological Phenomena
- What is being tested?
- Sodium bicarbonate and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2020
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
Who cannot join
- Smokers
- Chronic disease
- Prior or current use of steroids
- Use of creatine in the last 6 months
- Use of beta-alanine in the last 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance
The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).
- Being tested
- Sodium bicarbonate, Maltodextrin
- 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
Sodium bicarbonate in powder form ingested in gelatine capsules. This leads to an increase bicarbonate concentration in blood, increasing buffering capacity which may lead to improvements in exercise
MaltodextrinDietary supplement
Maltodextrin will be used as a placebo as it will not lead to any increases in circulating bicarbonate and, at this dose, will not likely have any physiological effect.
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | 0.3 g∙kg-1body mass of sodium bicarbonate Receives: Dietary Supplement: Sodium bicarbonate |
| Placebo | Placebo comparator | Individuals will ingest 0.3 g/kg maltodextrin before undergoing exercise Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H+ transporter activity
Change in activity of transporters related to H+
Measured: 5 minutes Post-exercise
Secondary outcomes (1)
Exercise performance
Change in 1 km cycling time-trial performance
Measured: 1 hour Post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study startAug 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
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
- NCT03505970
- Sponsor's protocol ID
- SB_BloodMuscle
- Status last verified
- Jun 2019
- First submitted
- 31 Mar 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance
- ClinicalTrials.gov ID
- NCT03505970
- Acronym / sponsor ID
- SB_BloodMuscle
- Keywords
- Physiological Phenomena
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Apr 2018 (actual)
- 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.
The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind crossover
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Dietary Supplement: Sodium bicarbonate0.3 g∙kg-1body mass of sodium bicarbonate |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinIndividuals will ingest 0.3 g/kg maltodextrin before undergoing exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males
Key exclusion criteria (5 listed)
- Smokers
- Chronic disease
- Prior or current use of steroids
- Use of creatine in the last 6 months
- Use of beta-alanine in the last 6 months
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 bicarbonateSodium bicarbonate in powder form ingested in gelatine capsules. This leads to an increase bicarbonate concentration in blood, increasing buffering capacity which may lead to improvements in exercise | Dietary supplement | Sodium bicarbonate |
| MaltodextrinMaltodextrin will be used as a placebo as it will not lead to any increases in circulating bicarbonate and, at this dose, will not likely have any physiological effect. | Dietary supplement | Placebo |
Primary outcome
H+ transporter activity
Time frame: 5 minutes Post-exercise
Change in activity of transporters related to H+
1 secondary outcome
Exercise performance
Time frame: 1 hour Post-supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate and Maltodextrin in people with Sports Nutritional Physiological Phenomena, run by University of Sao Paulo.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (3061-8789 ext. +55, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H+ transporter activity (time frame: 5 minutes Post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2019.