<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/NCT03837886</url>
  </required_header>
  <id_info>
    <org_study_id>FP001</org_study_id>
    <nct_id>NCT03837886</nct_id>
  </id_info>
  <brief_title>Effects of Sodium Bicarbonate Supplementation on Intermittent and Intense Task</brief_title>
  <official_title>Sodium Bicarbonate Supplementation Promotes Changes in Performance, Muscle Activity and Strength of Individuals Trained During the Performance of Intermittent and Intense Task? Randomized, Double-blind, Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marcelo Martins Kalytczak</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes&#xD;
      changes in the performance, muscular activity and strength of individuals trained during the&#xD;
      intermittent and intense task . Twelve trained adult men will participate in this randomized,&#xD;
      double-blind, crossover clinical trial. Each participant should receive two types of&#xD;
      intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous&#xD;
      capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3&#xD;
      g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered:&#xD;
      electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and&#xD;
      perception of effort, recovery and pain questionnaires, which will be collected during&#xD;
      intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to&#xD;
      verify possible differences between groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 20, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment</measure>
    <time_frame>60 minutes</time_frame>
    <description>The electromyographic activity will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets in an isokinetic dynamometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak torque assessed with isokinetic dynamometer equipment</measure>
    <time_frame>60 minutes</time_frame>
    <description>The peak torque will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactate assessed with portable lactometer</measure>
    <time_frame>15 seconds</time_frame>
    <description>The lactate quantification will be performed before and after the test session characterized by the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with an interval of 1 minute between sets in an isokinetic dynamometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Sodium Bicarbonate</condition>
  <condition>Alkalosis, Metabolic</condition>
  <condition>Electromyography</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Alkalosis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sodium bicarbonate</intervention_name>
    <description>The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.</description>
    <arm_group_label>Alkalosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium carbonate</intervention_name>
    <description>The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  resistance trained men (minimum 12 moths resistance training experience)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus;&#xD;
&#xD;
          -  respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;&#xD;
&#xD;
          -  acid-base balance disorder;&#xD;
&#xD;
          -  continuous use of some type of medication;&#xD;
&#xD;
          -  use of high-protein supplementation and creatine supplementation;&#xD;
&#xD;
          -  users of anabolic steroids.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marcelo M Kalytczak, PhD</last_name>
    <phone>55 11 981595139</phone>
    <email>marcelomkal@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nove de Julho University</name>
      <address>
        <city>São Paulo</city>
        <zip>06454050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>October 16, 2019</last_update_submitted>
  <last_update_submitted_qc>October 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Fabiano Politti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alkalosis</mesh_term>
  </condition_browse>
  <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>Undecided</sharing_ipd>
  </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/NCT03837886
org study id: FP001
nct id: NCT03837886
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes
      changes in the performance, muscular activity and strength of individuals trained during the
      intermittent and intense task . Twelve trained adult men will participate in this randomized,
      double-blind, crossover clinical trial. Each participant should receive two types of
      intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous
      capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3
      g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered:
      electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and
      perception of effort, recovery and pain questionnaires, which will be collected during
      intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to
      verify possible differences between groups.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment
time frame: 60 minutes
description: The electromyographic activity will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets in an isokinetic dynamometer.
measure: Peak torque assessed with isokinetic dynamometer equipment
time frame: 60 minutes
description: The peak torque will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets.
measure: Lactate assessed with portable lactometer
time frame: 15 seconds
description: The lactate quantification will be performed before and after the test session characterized by the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with an interval of 1 minute between sets in an isokinetic dynamometer.
arm group label: Alkalosis group
arm group type: Experimental
description: The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate
arm group label: Placebo group
arm group type: Placebo Comparator
description: The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
intervention type: Dietary Supplement
intervention name: Sodium bicarbonate
description: The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.
arm group label: Alkalosis group
intervention type: Dietary Supplement
intervention name: Calcium carbonate
description: The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelo M Kalytczak, PhD
phone: 55 11 981595139
email: marcelomkal@hotmail.com
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Fabiano Politti
investigator title: Principal Investigator
mesh term: Alkalosis
mesh term: Calcium Carbonate
mesh term: Calcium
sharing ipd: Undecided