<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/NCT03000582</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2014-0362F</org_study_id>
    <nct_id>NCT03000582</nct_id>
  </id_info>
  <brief_title>Assessment of Different Forms of Creatine</brief_title>
  <acronym>NB3</acronym>
  <official_title>Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine</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 pharmacokinetics of creatine nitrate&#xD;
      supplementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Creatine nitrate contains several nutrients that may increase anaerobic exercise performance.&#xD;
      Theoretically, dietary supplementation of creatine nitrate during resistance training can&#xD;
      improve the quality of training leading to greater changes in strength, power and fat free&#xD;
      mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular&#xD;
      health parameter that can be measured via ultrasonography, is a predictor of cardiovascular&#xD;
      disease risk which precedes traditional risk markers. Diet, physical activity and&#xD;
      pharmaceutical interventions can all impact vascular function and health. The purpose of this&#xD;
      study is to determine the acute vascular response of creatine nitrate supplementation on FMD&#xD;
      by analyzing the pharmacokinetics of creatine nitrate supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing body water</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing body composition</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure standard clinical chemistry panels in the blood to evaluate safety</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure side effects to evaluate safety utilizing a side effects questionnaire</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure heart rate to evaluate safety</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure blood pressure to evaluate safety</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Creatine monohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 gm creatine monohydrate, 1.5 gm dextrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Creatine nitrate-1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Creatine nitrate-2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6.5 gm dextrose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine monohydrate</intervention_name>
    <description>Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)</description>
    <arm_group_label>Creatine monohydrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine nitrate-1</intervention_name>
    <description>Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)</description>
    <arm_group_label>Creatine nitrate-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine nitrate-2</intervention_name>
    <description>Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)</description>
    <arm_group_label>Creatine nitrate-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (6.5 g dextrose)</description>
    <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;
        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 a history of smoking;&#xD;
&#xD;
          -  you drink excessively (i.e., 12 drinks per week or more);&#xD;
&#xD;
          -  you have a recent history of creatine supplementation within six weeks of the start of&#xD;
             supplementation;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 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/NCT03000582
org study id: IRB2014-0362F
nct id: NCT03000582
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine the pharmacokinetics of creatine nitrate
      supplementation.
Creatine nitrate contains several nutrients that may increase anaerobic exercise performance.
      Theoretically, dietary supplementation of creatine nitrate during resistance training can
      improve the quality of training leading to greater changes in strength, power and fat free
      mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular
      health parameter that can be measured via ultrasonography, is a predictor of cardiovascular
      disease risk which precedes traditional risk markers. Diet, physical activity and
      pharmaceutical interventions can all impact vascular function and health. The purpose of this
      study is to determine the acute vascular response of creatine nitrate supplementation on FMD
      by analyzing the pharmacokinetics of creatine nitrate supplementation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Examine creatine vs. creatine nitrate supplementation by assessing body water
time frame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing body composition
time frame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels
time frame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels
time frame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels
time frame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography
time frame: One day
measure: Measure standard clinical chemistry panels in the blood to evaluate safety
time frame: One day
measure: Measure side effects to evaluate safety utilizing a side effects questionnaire
time frame: One day
measure: Measure heart rate to evaluate safety
time frame: One day
measure: Measure blood pressure to evaluate safety
time frame: One day
arm group label: Creatine monohydrate
arm group type: Experimental
description: 5 gm creatine monohydrate, 1.5 gm dextrose
arm group label: Creatine nitrate-1
arm group type: Active Comparator
description: 1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose
arm group label: Creatine nitrate-2
arm group type: Active Comparator
description: 2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose
arm group label: Placebo
arm group type: Placebo Comparator
description: 6.5 gm dextrose
intervention type: Dietary Supplement
intervention name: Creatine monohydrate
description: Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)
arm group label: Creatine monohydrate
intervention type: Dietary Supplement
intervention name: Creatine nitrate-1
description: Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)
arm group label: Creatine nitrate-1
intervention type: Dietary Supplement
intervention name: Creatine nitrate-2
description: Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)
arm group label: Creatine nitrate-2
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo (6.5 g dextrose)
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No