<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/NCT03039829</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2015-0684</org_study_id>
    <nct_id>NCT03039829</nct_id>
  </id_info>
  <brief_title>Safety of Different Forms of Creatine</brief_title>
  <acronym>NB9</acronym>
  <official_title>Short-Term Safety and Dose Effects 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>
      This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses&#xD;
      will differentially affect hemodynamic variables compared to a placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate&#xD;
      (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and&#xD;
      blood pressure reactivity and self-reported side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Measuring the blood pressure response to creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring the heart rate response to creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring a blood chemistry panel 15 response to creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring self-reported side effects of creatine nitrate ingestion</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Nutritional Supplements</condition>
  <arm_group>
    <arm_group_label>Creatine nitrate, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Creatine nitrate, high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo at 6.0 grams dextrose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine nitrate, low dose</intervention_name>
    <description>Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)</description>
    <arm_group_label>Creatine nitrate, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine nitrate, high dose</intervention_name>
    <description>Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)</description>
    <arm_group_label>Creatine nitrate, high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo at 6.0 grams (6.0 grams dextrose)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy&#xD;
&#xD;
          -  At least 6 months immediate prior history of resistance training including bench press&#xD;
             and leg press or squat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of treatment for metabolic disease (i.e., diabetes), hypertension,&#xD;
             hypotension, thyroid disease, arrhythmias and/or cardiovascular disease&#xD;
&#xD;
          -  Use of prescription medication (birth control is allowed)&#xD;
&#xD;
          -  Pregnant or nursing or plan to become pregnant during the next month&#xD;
&#xD;
          -  Creatine or nitrate use in the last eight weeks&#xD;
&#xD;
          -  History of smoking&#xD;
&#xD;
          -  History of drinking (i.e., 12 drinks per week or more)&#xD;
&#xD;
          -  Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil,&#xD;
             Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan,&#xD;
             Naprosyn), piroxicam (Feldene)&#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 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 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/NCT03039829
org study id: IRB2015-0684
nct id: NCT03039829
lead sponsor: 
collaborator: 
has dmc: Yes
This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses
      will differentially affect hemodynamic variables compared to a placebo.
This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate
      (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and
      blood pressure reactivity and self-reported side effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Measuring the blood pressure response to creatine nitrate ingestion
time frame: 7 days
measure: Measuring the heart rate response to creatine nitrate ingestion
time frame: 7 days
measure: Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
time frame: 7 days
measure: Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
time frame: 7 days
measure: Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
time frame: 7 days
measure: Measuring self-reported side effects of creatine nitrate ingestion
time frame: 7 days
arm group label: Creatine nitrate, low dose
arm group type: Experimental
description: Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)
arm group label: Creatine nitrate, high dose
arm group type: Active Comparator
description: Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo at 6.0 grams dextrose
intervention type: Dietary Supplement
intervention name: Creatine nitrate, low dose
description: Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
arm group label: Creatine nitrate, low dose
intervention type: Dietary Supplement
intervention name: Creatine nitrate, high dose
description: Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
arm group label: Creatine nitrate, high dose
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo at 6.0 grams (6.0 grams 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