Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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:

-

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Amerigo Rossi, Assistant Professor, Long Island University
• ClinicalTrials.gov Identifier: NCT03813329
• Other Study ID Numbers: Rossi01
• First Posted: January 23, 2019
• 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)

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

Additional relevant MeSH terms:

Calcium Carbonate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents