<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/NCT03022604</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2014-0795F</org_study_id>
    <nct_id>NCT03022604</nct_id>
  </id_info>
  <brief_title>Assessment of a Pre-Workout Supplement</brief_title>
  <acronym>NB6</acronym>
  <official_title>Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutrabolt</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is assessing the effects of a pre-workout dietary supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the acute effects of a pre-workout dietary supplement&#xD;
      at a standard dose and one that is delivered at 150% of the standard dose on energy&#xD;
      metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on the Word Recall Test</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on bench press power output</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on leg press power output</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on total work on the bench press</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on total work on the leg press</measure>
    <time_frame>Seven Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on energy expenditure</measure>
    <time_frame>Seven Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on heart rate</measure>
    <time_frame>Seven Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on blood pressure</measure>
    <time_frame>Seven Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on ECG's</measure>
    <time_frame>Seven Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of a Pre-Workout Dietary Supplement on blood lab results</measure>
    <time_frame>Seven Days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Exercise Ergogenics</condition>
  <arm_group>
    <arm_group_label>C4/Generation 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 grams of C4/Generation 4 Extreme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C450X</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 grams of C4X (150% of regular dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 grams of flavored dextrose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>C4/Generation 4</intervention_name>
    <description>12 grams of C4/Generation 4</description>
    <arm_group_label>C4/Generation 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>C450X</intervention_name>
    <description>12 grams of C450X</description>
    <arm_group_label>C450X</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>12 grams of flavored dextrose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be apparently healthy males and/or females between the ages of 18&#xD;
             and 40&#xD;
&#xD;
          -  Participants must have at least 6 months immediate prior history of resistance&#xD;
             training including the bench press and leg press/squat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have a history of treatment for metabolic disease (i.e., diabetes),&#xD;
             hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease&#xD;
&#xD;
          -  Participants who currently use any prescription medication&#xD;
&#xD;
          -  Participants who are intolerant to caffeine and/or other natural stimulants&#xD;
&#xD;
          -  Participants who are pregnant or lactating women&#xD;
&#xD;
          -  Participants who have a history of smoking&#xD;
&#xD;
          -  Participants who drink excessively (12 drinks per week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard B Kreider, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03022604
org study id: IRB2014-0795F
nct id: NCT03022604
lead sponsor: 
collaborator: 
has dmc: Yes
This study is assessing the effects of a pre-workout dietary supplement.
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement
      at a standard dose and one that is delivered at 150% of the standard dose on energy
      metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on the Word Recall Test
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on bench press power output
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on leg press power output
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on total work on the bench press
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on total work on the leg press
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on energy expenditure
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on heart rate
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on blood pressure
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on ECG's
time frame: Seven Days
measure: Effects of a Pre-Workout Dietary Supplement on blood lab results
time frame: Seven Days
arm group label: C4/Generation 4
arm group type: Experimental
description: 12 grams of C4/Generation 4 Extreme
arm group label: C450X
arm group type: Active Comparator
description: 12 grams of C4X (150% of regular dose)
arm group label: Placebo
arm group type: Placebo Comparator
description: 12 grams of flavored dextrose
intervention type: Dietary Supplement
intervention name: C4/Generation 4
description: 12 grams of C4/Generation 4
arm group label: C4/Generation 4
intervention type: Dietary Supplement
intervention name: C450X
description: 12 grams of C450X
arm group label: C450X
intervention type: Dietary Supplement
intervention name: Placebo
description: 12 grams of flavored dextrose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard B Kreider, PhD
role: Principal Investigator
affiliation: Texas A&M University
responsible party type: Sponsor
sharing ipd: No