<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813329</url>
  </required_header>
  <id_info>
    <org_study_id>Rossi01</org_study_id>
    <nct_id>NCT03813329</nct_id>
  </id_info>
  <brief_title>Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity</brief_title>
  <official_title>The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Long Island University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California State University, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Long Island University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One purpose of the present study was to evaluate the effect of elevating serum bicarbonate&#xD;
      concentration more than had been achieved in previous studies without inducing potentially&#xD;
      ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4&#xD;
      progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized&#xD;
      that ModSB would significantly elevate serum bicarbonate concentration to a greater extent&#xD;
      than would an acute SB ingestion protocol (AcuteSB).&#xD;
&#xD;
      This study was also designed to corroborate the results of previous studies regarding the&#xD;
      ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium&#xD;
      bicarbonate in solutions, which would make the participants aware of the substance ingested&#xD;
      due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the&#xD;
      present study were administered in gelatin capsules to mask the flavor of the ingested&#xD;
      substances, maintaining participant blindness to the procedure.&#xD;
&#xD;
      Blood samples were collected at baseline and following placebo (CaCO3), acute sodium&#xD;
      bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of&#xD;
      the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as&#xD;
      on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2004</start_date>
  <completion_date type="Actual">December 31, 2005</completion_date>
  <primary_completion_date type="Actual">October 31, 2004</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Opaque gelatin capsules</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of serum sodium bicarbonate (mmol·L-1)</measure>
    <time_frame>24 hours</time_frame>
    <description>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.&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum sodium (mmol·L-1)</measure>
    <time_frame>24 hours</time_frame>
    <description>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.&#xD;
One vial was analyzed for sodium concentration (Vitros DT60 II, Ortho-Clinical Diagnostics, Rochester, NY)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH</measure>
    <time_frame>24 hours</time_frame>
    <description>The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood hematocrit (%)</measure>
    <time_frame>24 hours</time_frame>
    <description>Blood was drawn via venipuncture. Two capillary tubes were immediately filled from the blood samples to be tested for hematocrit via the microhematocrit method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likert scale for self-reported gastrointestinal distress (1-10)</measure>
    <time_frame>24 hours</time_frame>
    <description>Gastrointestinal distress was assessed via self-report on a Likert scale of 1-10.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>PERFORMANCE-ENHANCING EFFECT</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Sodium Bicarbonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Sodium Bicarbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Modified Sodium Bicarbonate</intervention_name>
    <description>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate</description>
    <arm_group_label>Acute Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Modified Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Acute Sodium Bicarbonate</intervention_name>
    <description>3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)</description>
    <arm_group_label>Acute Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Modified Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium carbonate (placebo)</intervention_name>
    <description>4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate</description>
    <arm_group_label>Acute Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Modified Sodium Bicarbonate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1&#xD;
             (women)&#xD;
&#xD;
          -  Currently training; defined as at least 5 days·week-1 of running&#xD;
&#xD;
          -  Elite-level performance (750 or more points on the International Associations of&#xD;
             Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Long Island University</investigator_affiliation>
    <investigator_full_name>Amerigo Rossi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813329
org study id: Rossi01
nct id: NCT03813329
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
masking description: Opaque gelatin capsules
measure: Concentration of serum sodium bicarbonate (mmol·L-1)
time frame: 24 hours
description: 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).
measure: Concentration of serum sodium (mmol·L-1)
time frame: 24 hours
description: 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)
measure: pH
time frame: 24 hours
description: The serum in one vial was immediately analyzed for pH using the Orion 720A+ (Thermo Electron Corporation, Waltham, MA)
measure: Blood hematocrit (%)
time frame: 24 hours
description: Blood was drawn via venipuncture. Two capillary tubes were immediately filled from the blood samples to be tested for hematocrit via the microhematocrit method.
measure: Likert scale for self-reported gastrointestinal distress (1-10)
time frame: 24 hours
description: Gastrointestinal distress was assessed via self-report on a Likert scale of 1-10.
arm group label: Placebo
arm group type: Placebo Comparator
description: 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate
arm group label: Acute Sodium Bicarbonate
arm group type: Active Comparator
description: 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.
arm group label: Modified Sodium Bicarbonate
arm group type: Experimental
description: 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate
intervention type: Dietary Supplement
intervention name: Modified Sodium Bicarbonate
description: 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate
arm group label: Acute Sodium Bicarbonate
arm group label: Modified Sodium Bicarbonate
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Acute Sodium Bicarbonate
description: 3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)
arm group label: Acute Sodium Bicarbonate
arm group label: Modified Sodium Bicarbonate
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Calcium carbonate (placebo)
description: 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate
arm group label: Acute Sodium Bicarbonate
arm group label: Modified Sodium Bicarbonate
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Long Island University
investigator full name: Amerigo Rossi
investigator title: Assistant Professor
mesh term: Calcium Carbonate
mesh term: Calcium
sharing ipd: Yes
ipd description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)