Sodium BicarbonateNCT03837886
Effects of Sodium Bicarbonate Supplementation on Intermittent and Intense Task
A study testing Sodium bicarbonate and Calcium carbonate in people with Sodium Bicarbonate and Alkalosis, Metabolic, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 42 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sodium Bicarbonate, Alkalosis, Metabolic, Electromyography
- What is being tested?
- Sodium bicarbonate and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2019to 30 Nov 2019
- 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 20 to 42 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- resistance trained men (minimum 12 moths resistance training experience)
Who cannot join
- diabetes mellitus;
- respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;
- acid-base balance disorder;
- continuous use of some type of medication;
- use of high-protein supplementation and creatine supplementation;
- users of anabolic steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Bicarbonate Supplementation Promotes Changes in Performance, Muscle Activity and Strength of Individuals Trained During the Performance of Intermittent and Intense Task? Randomized, Double-blind, Crossover Trial
The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. Each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3 g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered: electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to verify possible differences between groups.
- Conditions
- Sodium Bicarbonate, Alkalosis, Metabolic, Electromyography, Fatigue
- Being tested
- Sodium bicarbonate, Calcium carbonate
- Medical subject headings
- Alkalosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDietary supplement
The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.
Calcium carbonateDietary supplement
The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
| Study group | Role | What they receive |
|---|---|---|
| Alkalosis group | Experimental | The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate Receives: Dietary Supplement: Sodium bicarbonate |
| Placebo group | Placebo comparator | The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate Receives: Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment
The electromyographic activity will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets in an isokinetic dynamometer.
Measured: 60 minutes
Peak torque assessed with isokinetic dynamometer equipment
The peak torque will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets.
Measured: 60 minutes
Secondary outcomes (1)
Lactate assessed with portable lactometer
The lactate quantification will be performed before and after the test session characterized by the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with an interval of 1 minute between sets in an isokinetic dynamometer.
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start20 Oct 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium BicarbonateStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Marcelo Martins Kalytczak
- Responsible party
- Principal investigator, Fabiano Politti, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837886
- Sponsor's protocol ID
- FP001
- Status last verified
- Oct 2019
- First submitted
- 6 Feb 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate Supplementation Promotes Changes in Performance, Muscle Activity and Strength of Individuals Trained During the Performance of Intermittent and Intense Task? Randomized, Double-blind, Crossover Trial
- ClinicalTrials.gov ID
- NCT03837886
- Acronym / sponsor ID
- FP001
- Conditions
- Sodium Bicarbonate, Alkalosis, Metabolic, Electromyography, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Marcelo Martins Kalytczak
- Study start
- 20 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 12 Feb 2019 (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 was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. Each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3 g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered: electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to verify possible differences between groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alkalosis group | Experimental | Dietary Supplement: Sodium bicarbonateThe subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate |
| Placebo group | Placebo comparator | Dietary Supplement: Calcium carbonateThe subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- resistance trained men (minimum 12 moths resistance training experience)
Key exclusion criteria (6 listed)
- diabetes mellitus;
- respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;
- acid-base balance disorder;
- continuous use of some type of medication;
- use of high-protein supplementation and creatine supplementation;
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 bicarbonateThe subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task. | Dietary supplement | Alkalosis group |
| Calcium carbonateThe subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate | Dietary supplement | Placebo group |
Primary outcome
Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment
Time frame: 60 minutes
The electromyographic activity will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets in an isokinetic dynamometer.
Peak torque assessed with isokinetic dynamometer equipment
Time frame: 60 minutes
The peak torque will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets.
1 secondary outcome
Lactate assessed with portable lactometer
Time frame: 15 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Sodium Bicarbonate and Alkalosis, Metabolic, run by University of Nove de Julho 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 6 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 17 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo M Kalytczak, PhD (55 11 981595139, marcelomkal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 17 Oct 2019.