<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/NCT03003988</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2014-0503FX</org_study_id>
    <nct_id>NCT03003988</nct_id>
  </id_info>
  <brief_title>Physiological Effects of Creatine Supplementation in Active Males</brief_title>
  <acronym>NB4</acronym>
  <official_title>Effects of 28 Days of Different Forms of Creatine Supplementation on Muscle Creatine, Body Composition and Exercise Performance in Recreationally Active Males</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 was designed to examine how different forms of creatine impact active males.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examined the effects of different formulations of creatine nitrate on muscle&#xD;
      creatine content, body composition, anaerobic exercise capacity, bench press performance and&#xD;
      clinical chemistry panels in recreationally active males.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 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>Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing Body Water through Bioelectrical Impedance Analysis (BIA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on Body Composition</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing Body Compositing through Dual-Energy X-Ray Absorptiometry (DXA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular creatine</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing intramuscular creatine using standard spectrophotometric methods using a microplate spectrophotometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular phosphocreatine</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing intramuscular phosphocreatine using standard spectrophotometric methods using a microplate spectrophotometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular ATP</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing intramuscular Adenosine Triphosphate (ATP) using standard spectrophotometric methods using a microplate spectrophotometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing muscular strength through 1 Repetition Maximum (RM) testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing muscular endurance through repetition to failure testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on anaerobic capacity</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing anaerobic capacity through 6 x 6 second sprints followed by a 30 second sprint on a Wingate bicycle ergometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing training volume using a calculator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects</measure>
    <time_frame>28 Days</time_frame>
    <description>Assessing self-reported side effects using a side effects questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of 28 Days of Different Forms of Creatine Supplementation on blood</measure>
    <time_frame>28 Days</time_frame>
    <description>Measure standard clinical chemistry panels in the blood to evaluate safety</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Dietary Supplementation</condition>
  <arm_group>
    <arm_group_label>Creatine monohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creatine monohydrate (6.0 g.) + dextrose (0.5 g.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Creatine nitrate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Creatine nitrate (5.0 g. creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6.5 g. dextrose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine monohydrate</intervention_name>
    <description>Creatine monohydrate (6.0 g) + dextrose (0.5 g)</description>
    <arm_group_label>Creatine monohydrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine nitrate</intervention_name>
    <description>Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio)</description>
    <arm_group_label>Creatine nitrate</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;
          -  participants are apparently healthy and recreationally active males between the ages&#xD;
             of 18 and 40;&#xD;
&#xD;
          -  participants will need to have at least six months immediate prior history of&#xD;
             resistance training on the bench press and leg press or squat;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants have a history of treatment for metabolic disease (i.e., diabetes),&#xD;
             hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease;&#xD;
&#xD;
          -  participants are currently using prescription medications;&#xD;
&#xD;
          -  participants have a history of smoking;&#xD;
&#xD;
          -  participants drink excessively (i.e., 12 drinks per week or more);&#xD;
&#xD;
          -  participants have a recent history of creatine supplementation within six weeks of the&#xD;
             start of supplementation;&#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>
  <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>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 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/NCT03003988
org study id: IRB2014-0503FX
nct id: NCT03003988
lead sponsor: 
collaborator: 
has dmc: Yes
This study was designed to examine how different forms of creatine impact active males.
This study examined the effects of different formulations of creatine nitrate on muscle
      creatine content, body composition, anaerobic exercise capacity, bench press performance and
      clinical chemistry panels in recreationally active males.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water
time frame: 28 Days
description: Assessing Body Water through Bioelectrical Impedance Analysis (BIA)
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on Body Composition
time frame: 28 Days
description: Assessing Body Compositing through Dual-Energy X-Ray Absorptiometry (DXA)
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular creatine
time frame: 28 Days
description: Assessing intramuscular creatine using standard spectrophotometric methods using a microplate spectrophotometer
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular phosphocreatine
time frame: 28 Days
description: Assessing intramuscular phosphocreatine using standard spectrophotometric methods using a microplate spectrophotometer
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular ATP
time frame: 28 Days
description: Assessing intramuscular Adenosine Triphosphate (ATP) using standard spectrophotometric methods using a microplate spectrophotometer
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength
time frame: 28 Days
description: Assessing muscular strength through 1 Repetition Maximum (RM) testing
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance
time frame: 28 Days
description: Assessing muscular endurance through repetition to failure testing
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on anaerobic capacity
time frame: 28 Days
description: Assessing anaerobic capacity through 6 x 6 second sprints followed by a 30 second sprint on a Wingate bicycle ergometer
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)
time frame: 28 Days
description: Assessing training volume using a calculator
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects
time frame: 28 Days
description: Assessing self-reported side effects using a side effects questionnaire
measure: Effects of 28 Days of Different Forms of Creatine Supplementation on blood
time frame: 28 Days
description: Measure standard clinical chemistry panels in the blood to evaluate safety
arm group label: Creatine monohydrate
arm group type: Experimental
description: Creatine monohydrate (6.0 g.) + dextrose (0.5 g.)
arm group label: Creatine nitrate
arm group type: Active Comparator
description: Creatine nitrate (5.0 g. creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio).
arm group label: Placebo
arm group type: Placebo Comparator
description: 6.5 g. dextrose
intervention type: Dietary Supplement
intervention name: Creatine monohydrate
description: Creatine monohydrate (6.0 g) + dextrose (0.5 g)
arm group label: Creatine monohydrate
intervention type: Dietary Supplement
intervention name: Creatine nitrate
description: Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio)
arm group label: Creatine nitrate
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo (6.5 g dextrose)
arm group label: Placebo
criteria: 
gender: Male
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