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Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

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ClinicalTrials.gov Identifier: NCT03813329
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
California State University, Los Angeles
Information provided by (Responsible Party):
Amerigo Rossi, 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.


Condition or disease Intervention/treatment Phase
PERFORMANCE-ENHANCING EFFECT Dietary Supplement: Modified Sodium Bicarbonate Dietary Supplement: Acute Sodium Bicarbonate Dietary Supplement: Calcium carbonate (placebo) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Opaque gelatin capsules
Primary Purpose: Basic Science
Official Title: The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial
Actual Study Start Date : May 1, 2004
Actual Primary Completion Date : October 31, 2004
Actual Study Completion Date : December 31, 2005

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


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Responsible Party: Amerigo Rossi, Assistant Professor, Long Island University
ClinicalTrials.gov Identifier: NCT03813329     History of Changes
Other Study ID Numbers: Rossi01
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Calcium, Dietary
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents