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Completed

NCT Number: NCT03813329

Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

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.

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Key information

Conditions

PERFORMANCE-ENHANCING EFFECT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Modified Sodium Bicarbonate

Dietary Supplement

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate

Acute Sodium Bicarbonate

Dietary 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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Concentration of serum sodium (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 analyzed for sodium concentration (Vitros DT60 II, Ortho-Clinical Diagnostics, Rochester, NY)

  2. pH

    Time frame: 24 hours

    The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)

  3. Blood hematocrit (%)

    Time frame: 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.

  4. Likert scale for self-reported gastrointestinal distress (1-10)

    Time frame: 24 hours

    Gastrointestinal distress was assessed via self-report on a Likert scale of 1-10.

Sponsors and collaborators

Lead sponsor

Long Island University

Other

Collaborators

  • California State University, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Jan 23, 2019
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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