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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

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE May 1, 2004
Actual Primary Completion Date October 31, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • 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)
  • pH [ Time Frame: 24 hours ]
    The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity
Official Title  ICMJE The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Opaque gelatin capsules
Primary Purpose: Basic Science
Condition  ICMJE PERFORMANCE-ENHANCING EFFECT
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate
    Interventions:
    • Dietary Supplement: Modified Sodium Bicarbonate
    • Dietary Supplement: Acute Sodium Bicarbonate
    • Dietary Supplement: Calcium carbonate (placebo)
  • 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.
    Interventions:
    • Dietary Supplement: Modified Sodium Bicarbonate
    • Dietary Supplement: Acute Sodium Bicarbonate
    • Dietary Supplement: Calcium carbonate (placebo)
  • Experimental: Modified Sodium Bicarbonate
    4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate
    Interventions:
    • Dietary Supplement: Modified Sodium Bicarbonate
    • Dietary Supplement: Acute Sodium Bicarbonate
    • Dietary Supplement: Calcium carbonate (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2019)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2005
Actual Primary Completion Date October 31, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03813329
Other Study ID Numbers  ICMJE Rossi01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Amerigo Rossi, Long Island University
Study Sponsor  ICMJE Long Island University
Collaborators  ICMJE California State University, Los Angeles
Investigators  ICMJE Not Provided
PRS Account Long Island University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP