Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

NCT ID: NCT03813329

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-01

Study Completion Date

2005-12-31

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.

Detailed Description

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Conditions

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PERFORMANCE-ENHANCING EFFECT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Opaque gelatin capsules

Study Groups

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Placebo

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate

Group Type PLACEBO_COMPARATOR

Modified Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)

Calcium carbonate (placebo)

Intervention Type DIETARY_SUPPLEMENT

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate

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.

Group Type ACTIVE_COMPARATOR

Modified Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)

Calcium carbonate (placebo)

Intervention Type DIETARY_SUPPLEMENT

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate

Modified Sodium Bicarbonate

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

Group Type EXPERIMENTAL

Modified Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate

Intervention Type DIETARY_SUPPLEMENT

3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)

Calcium carbonate (placebo)

Intervention Type DIETARY_SUPPLEMENT

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate

Interventions

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Modified Sodium Bicarbonate

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

Intervention Type DIETARY_SUPPLEMENT

Acute Sodium Bicarbonate

3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)

Intervention Type DIETARY_SUPPLEMENT

Calcium carbonate (placebo)

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California State University, Los Angeles

OTHER

Sponsor Role collaborator

Long Island University

OTHER

Sponsor Role lead

Responsible Party

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Amerigo Rossi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31533750 (View on PubMed)

Other Identifiers

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Rossi01

Identifier Type: -

Identifier Source: org_study_id

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