Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

Early Phase 1

Completed

• Conditions: PERFORMANCE-ENHANCING EFFECT

• Registration Number: NCT03813329
• Lead Sponsor: Long Island University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-01
• Primary Completion: 2004-10-31
• Study Completion: 2005-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Concentration of serum sodium bicarbonate (mmol·L-1)	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).

Secondary Outcome Measures

Name	Time	Method
pH	24 hours	The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)
Blood hematocrit (%)	24 hours	Blood was drawn via venipuncture. Two capillary tubes were immediately filled from the blood samples to be tested for hematocrit via the microhematocrit method.
Concentration of serum sodium (mmol·L-1)	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 analyzed for sodium concentration (Vitros DT60 II, Ortho-Clinical Diagnostics, Rochester, NY)
Likert scale for self-reported gastrointestinal distress (1-10)	24 hours	Gastrointestinal distress was assessed via self-report on a Likert scale of 1-10.