Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

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.

Study Overview

• Status: Completed
• Conditions: PERFORMANCE-ENHANCING EFFECT
• Intervention / Treatment: Dietary supplement: Modified Sodium Bicarbonate; Dietary supplement: Acute Sodium Bicarbonate; Dietary supplement: Calcium carbonate (placebo)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Long Island University
• Collaborators: California State University, Los Angeles

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2004
• Primary Completion (Actual): October 31, 2004
• Study Completion (Actual): December 31, 2005

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: Rossi01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No