<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/NCT02999581</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2014-0079FX</org_study_id>
    <nct_id>NCT02999581</nct_id>
  </id_info>
  <brief_title>Effects of a Pre-Workout Dietary Supplement on Training Adaptations</brief_title>
  <acronym>NB2</acronym>
  <official_title>Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes</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>
      The purpose of this study is to examine the effects of a pre-workout dietary supplement&#xD;
      during resistance training on training adaptations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of nutritional strategies have been developed to optimize nutrient delivery prior to&#xD;
      exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to,&#xD;
      during and/or following exercise. As a result, a number of pre-workout supplements have been&#xD;
      developed to increase energy availability, promote vasodilation and/or positively affect&#xD;
      exercise capacity. The purpose of this study is to investigate the effects of ingesting a&#xD;
      pre-workout dietary supplement during resistance training on training adaptations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing body water</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing body composition</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS)</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure standard clinical chemistry panels in the blood to evaluate safety</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Record side effects to evaluate safety</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure heart rate to evaluate safety</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure blood pressure to evaluate safety</measure>
    <time_frame>Eight weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>C4 Extreme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C4 Extreme (without Advantra Z)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One dose of flavored placebo (powder mixed with water)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>C4 Extreme, C4 Extreme (without Advantra Z)</intervention_name>
    <arm_group_label>C4 Extreme</arm_group_label>
    <arm_group_label>C4 Extreme (without Advantra Z)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  you are an apparently healthy and recreationally active male between the ages of 18&#xD;
             and 40.&#xD;
&#xD;
          -  you will need to have at least six months immediate prior history of resistance&#xD;
             training on the bench press and leg press or squat.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  you have a history of treatment for metabolic disease (i.e., diabetes), hypertension,&#xD;
             hypotension, thyroid disease, arrhythmia and/or cardiovascular disease;&#xD;
&#xD;
          -  you are currently using prescription medications;&#xD;
&#xD;
          -  you have an intolerance to caffeine and/or other natural stimulants;&#xD;
&#xD;
          -  you have a history of smoking;&#xD;
&#xD;
          -  you drink excessively (i.e., 12 drinks per week or more);&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</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/NCT02999581
org study id: IRB2014-0079FX
nct id: NCT02999581
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine the effects of a pre-workout dietary supplement
      during resistance training on training adaptations.
A number of nutritional strategies have been developed to optimize nutrient delivery prior to
      exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to,
      during and/or following exercise. As a result, a number of pre-workout supplements have been
      developed to increase energy availability, promote vasodilation and/or positively affect
      exercise capacity. The purpose of this study is to investigate the effects of ingesting a
      pre-workout dietary supplement during resistance training on training adaptations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Examine the effects of C4 supplementation during resistance training by assessing body water
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing body composition
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels
time frame: Eight weeks
measure: Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS)
time frame: Eight weeks
measure: Measure standard clinical chemistry panels in the blood to evaluate safety
time frame: Eight weeks
measure: Record side effects to evaluate safety
time frame: Eight weeks
measure: Measure heart rate to evaluate safety
time frame: Eight weeks
measure: Measure blood pressure to evaluate safety
time frame: Eight weeks
arm group label: C4 Extreme
arm group type: Experimental
description: One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.
arm group label: C4 Extreme (without Advantra Z)
arm group type: Active Comparator
description: One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.
arm group label: Placebo
arm group type: Placebo Comparator
description: One dose of flavored placebo (powder mixed with water)
intervention type: Dietary Supplement
intervention name: C4 Extreme, C4 Extreme (without Advantra Z)
arm group label: C4 Extreme
arm group label: C4 Extreme (without Advantra Z)
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No