PERFORMANCE-ENHANCING EFFECTEarly Phase 1NCT03813329
Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity
A Early Phase 1 study testing Modified Sodium Bicarbonate and Acute Sodium Bicarbonate in people with PERFORMANCE-ENHANCING EFFECT, run by Long Island University.
Trial summary
One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PERFORMANCE-ENHANCING EFFECT
- What is being tested?
- Modified Sodium Bicarbonate and Acute Sodium Bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2004to 31 Dec 2005
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1 (women)
- Currently training; defined as at least 5 days·week-1 of running
- Elite-level performance (750 or more points on the International Associations of Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6 months.
Who cannot join
- -
About this study
Official title: The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial
One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized that ModSB would significantly elevate serum bicarbonate concentration to a greater extent than would an acute SB ingestion protocol (AcuteSB).
This study was also designed to corroborate the results of previous studies regarding the ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium bicarbonate in solutions, which would make the participants aware of the substance ingested due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the present study were administered in gelatin capsules to mask the flavor of the ingested substances, maintaining participant blindness to the procedure.
Blood samples were collected at baseline and following placebo (CaCO3), acute sodium bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.
- Conditions
- PERFORMANCE-ENHANCING EFFECT
- Being tested
- Modified Sodium Bicarbonate, Acute Sodium Bicarbonate, Calcium carbonate (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Sodium BicarbonateDietary supplement
4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate
Acute Sodium BicarbonateDietary supplement
3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)
Calcium carbonate (placebo)Dietary supplement
4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate Receives: Dietary Supplement: Modified Sodium Bicarbonate; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo) |
| Acute Sodium Bicarbonate | Active comparator | 3 doses of calcium carbonate (110 mg·kg-1, 130 mg·kg-1, 160 mg·kg-1), followed by one acute does (300 mg·kg-1) of sodium bicarbonate. Receives: Dietary Supplement: Modified Sodium Bicarbonate; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo) |
| Modified Sodium Bicarbonate | Experimental | 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate Receives: Dietary Supplement: Modified Sodium Bicarbonate; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum sodium bicarbonate (mmol·L-1)
Blood was drawn via venipuncture and allowed to coagulate at room temperature for 25 minutes and then spun in a refrigerated centrifuge for 10 minutes. The serum was pipetted into three small vials.
One vial was tested for bicarbonate concentration in duplicate with a carbon dioxide liquid stable reagent method (TR28321, Thermo Electron Corporation, Waltham, MA) using a spectrophotometer (Lambda 20, PerkinElmer, Waltham, MA).
Measured: 24 hours
Secondary outcomes (4)
Concentration of serum sodium (mmol·L-1)
Blood was drawn via venipuncture and allowed to coagulate at room temperature for 25 minutes and then spun in a refrigerated centrifuge for 10 minutes. The serum was pipetted into three small vials.
One vial was analyzed for sodium concentration (Vitros DT60 II, Ortho-Clinical Diagnostics, Rochester, NY)
Measured: 24 hours
pH
The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)
Measured: 24 hours
Blood hematocrit (%)
Blood was drawn via venipuncture. Two capillary tubes were immediately filled from the blood samples to be tested for hematocrit via the microhematocrit method.
Measured: 24 hours
Likert scale for self-reported gastrointestinal distress (1-10)
Gastrointestinal distress was assessed via self-report on a Likert scale of 1-10.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 May 2004
- Primary completion31 Oct 2004
- Study completion31 Dec 2005
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 PERFORMANCE-ENHANCING EFFECTStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Long Island University
- Sponsor type
- University, hospital or other
- Collaborators
- California State University, Los Angeles
- Responsible party
- Principal investigator, Amerigo Rossi, Long Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813329
- Sponsor's protocol ID
- Rossi01
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Marcus A, Rossi A, Cornwell A, Hawkins SA, Khodiguian N. The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial. J Int Soc Sports Nutr. 2019 Sep 18;16(1):41. doi: 10.1186/s12970-019-0309-4.
PubMed 31533750
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03813329
- Acronym / sponsor ID
- Rossi01
- Conditions
- PERFORMANCE-ENHANCING EFFECT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Long Island UniversityUniversity, hospital or other
- Collaborators
- California State University, Los Angeles
- Study start
- 1 May 2004 (actual)
- Primary completion
- 31 Oct 2004 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 23 Jan 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.
One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized that ModSB would significantly elevate serum bicarbonate concentration to a greater extent than would an acute SB ingestion protocol (AcuteSB).
This study was also designed to corroborate the results of previous studies regarding the ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium bicarbonate in solutions, which would make the participants aware of the substance ingested due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the present study were administered in gelatin capsules to mask the flavor of the ingested substances, maintaining participant blindness to the procedure.
Blood samples were collected at baseline and following placebo (CaCO3), acute sodium bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Modified Sodium Bicarbonate, Dietary Supplement: Acute Sodium Bicarbonate, Dietary Supplement: Calcium carbonate (placebo)4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate |
| Acute Sodium Bicarbonate | Active comparator | Dietary Supplement: Modified Sodium Bicarbonate, Dietary Supplement: Acute Sodium Bicarbonate, Dietary Supplement: Calcium carbonate (placebo)3 doses of calcium carbonate (110 mg·kg-1, 130 mg·kg-1, 160 mg·kg-1), followed by one acute does (300 mg·kg-1) of sodium bicarbonate. |
| Modified Sodium Bicarbonate | Experimental | Dietary Supplement: Modified Sodium Bicarbonate, Dietary Supplement: Acute Sodium Bicarbonate, Dietary Supplement: Calcium carbonate (placebo)4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1 (women)
- Currently training; defined as at least 5 days·week-1 of running
- Elite-level performance (750 or more points on the International Associations of Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6 months.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Modified Sodium Bicarbonate4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate | Dietary supplement | Acute Sodium Bicarbonate, Modified Sodium Bicarbonate, Placebo |
| Acute Sodium Bicarbonate3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg) | Dietary supplement | Acute Sodium Bicarbonate, Modified Sodium Bicarbonate, Placebo |
| Calcium carbonate (placebo)4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate | Dietary supplement | Acute Sodium Bicarbonate, Modified Sodium Bicarbonate, Placebo |
Primary outcome
Concentration of serum sodium bicarbonate (mmol·L-1)
Time frame: 24 hours
Blood was drawn via venipuncture and allowed to coagulate at room temperature for 25 minutes and then spun in a refrigerated centrifuge for 10 minutes. The serum was pipetted into three small vials. One vial was tested for bicarbonate concentration in duplicate with a carbon dioxide liquid stable reagent method (TR28321, Thermo Electron Corporation, Waltham, MA) using a spectrophotometer (Lambda 20, PerkinElmer, Waltham, MA).
4 secondary outcomes
Concentration of serum sodium (mmol·L-1)
Time frame: 24 hours
pH
Time frame: 24 hours
Blood hematocrit (%)
Time frame: 24 hours
Likert scale for self-reported gastrointestinal distress (1-10)
Time frame: 24 hours
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 23 Jan 2019.
- Derived from this study: PubMed 31533750Marcus A, Rossi A, Cornwell A, Hawkins SA, Khodiguian N. The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial. J Int Soc Sports Nutr. 2019 Sep 18;16(1):41. doi: 10.1186/s12970-019-0309-4.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Modified Sodium Bicarbonate and Acute Sodium Bicarbonate in people with PERFORMANCE-ENHANCING EFFECT, run by Long Island University.
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 3 inclusion and 1 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 23 Jan 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Concentration of serum sodium bicarbonate (mmol·L-1) (time frame: 24 hours). 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 NCT03813329, 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 23 Jan 2019.