Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

NCT03813329 | Completed Early Phase 1

• 1 other identifier: Rossi01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PERFORMANCE-ENHANCING EFFECT

Outcome Measures

Primary Outcomes (1)

• Concentration of serum sodium bicarbonate (mmol·L-1)

  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).

  24 hours

Secondary Outcomes (4)

• Concentration of serum sodium (mmol·L-1)

  24 hours

• pH

  24 hours

• Blood hematocrit (%)

  24 hours

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

  24 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Modified Sodium Bicarbonate; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo)

Acute Sodium Bicarbonate

ACTIVE COMPARATOR

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; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo)

Modified Sodium Bicarbonate

EXPERIMENTAL

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

Dietary Supplement: Modified Sodium Bicarbonate; Dietary Supplement: Acute Sodium Bicarbonate; Dietary Supplement: Calcium carbonate (placebo)

Interventions

Modified Sodium Bicarbonate DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate; Modified Sodium Bicarbonate; Placebo

Acute Sodium Bicarbonate DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate; Modified Sodium Bicarbonate; Placebo

Calcium carbonate (placebo) DIETARY_SUPPLEMENT

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

Acute Sodium Bicarbonate; Modified Sodium Bicarbonate; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Long Island University: lead
• California State University, Los Angeles: collaborator

Related Publications (1)

• 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.

  PMID: 31533750 DERIVED

MeSH Terms

Interventions

Calcium Carbonate

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Opaque gelatin capsules
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: May 1, 2004
• Primary Completion: October 31, 2004
• Study Completion: December 31, 2005
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR