Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial

Conditions
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PERFORMANCE-ENHANCING EFFECT

Intervention / Treatment
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* Dietary Supplement: Modified Sodium Bicarbonate
* Dietary Supplement: Acute Sodium Bicarbonate
* Dietary Supplement: Calcium carbonate (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate | Dietary Supplement: Modified Sodium Bicarbonate<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate<br>Dietary Supplement: Acute Sodium Bicarbonate<br>* 3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)<br>Dietary Supplement: Calcium carbonate (placebo)<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate<br>|
| Active Comparator: Acute Sodium Bicarbonate<br>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. | Dietary Supplement: Modified Sodium Bicarbonate<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate<br>Dietary Supplement: Acute Sodium Bicarbonate<br>* 3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)<br>Dietary Supplement: Calcium carbonate (placebo)<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate<br>|
| Experimental: Modified Sodium Bicarbonate<br>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate | Dietary Supplement: Modified Sodium Bicarbonate<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate<br>Dietary Supplement: Acute Sodium Bicarbonate<br>* 3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)<br>Dietary Supplement: Calcium carbonate (placebo)<br>* 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 hours | 
| pH | The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA) | 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. | 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. | 24 hours |