<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/NCT03032549</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2015-0754</org_study_id>
    <nct_id>NCT03032549</nct_id>
  </id_info>
  <brief_title>Safety of a Ready to Drink Supplement</brief_title>
  <acronym>NB10</acronym>
  <official_title>Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine a Ready to Drink (RTD) supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink&#xD;
      (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and&#xD;
      self-reported side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 1, 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>The effects of ingesting an RTD immediately prior to exercise on the blood</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The effects of ingesting an RTD immediately prior to exercise on heart rate</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The effects of ingesting an RTD immediately prior to exercise on blood pressure</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of ingesting an RTD immediately prior to exercise on self-reported side effects</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Dietary Supplements</condition>
  <arm_group>
    <arm_group_label>RTD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>dextrose and non-caloric flavoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>RTD</intervention_name>
    <description>Ready to Drink Supplement</description>
    <arm_group_label>RTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are apparently healthy and recreationally active males and females&#xD;
             between the ages of 18 and 40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants are under 18 years old and above 40 years old&#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 currently use any prescription medication (birth control is allowed)&#xD;
&#xD;
          -  Participants are pregnant or lactating females or plan to become pregnant within the&#xD;
             next month&#xD;
&#xD;
          -  Participants have a history of smoking&#xD;
&#xD;
          -  Participants drink excessively (12 drinks per week or more)&#xD;
&#xD;
          -  Participants have a recent history of creatine supplementation within 8 weeks of the&#xD;
             start of supplementation&#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 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 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/NCT03032549
org study id: IRB2015-0754
nct id: NCT03032549
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine a Ready to Drink (RTD) supplement.
This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink
      (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and
      self-reported side effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: The effects of ingesting an RTD immediately prior to exercise on the blood
time frame: 7 days
measure: The effects of ingesting an RTD immediately prior to exercise on heart rate
time frame: 7 days
measure: The effects of ingesting an RTD immediately prior to exercise on blood pressure
time frame: 7 days
measure: The effects of ingesting an RTD immediately prior to exercise on self-reported side effects
time frame: 7 days
arm group label: RTD
arm group type: Experimental
description: 2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12
arm group label: Placebo
arm group type: Placebo Comparator
description: dextrose and non-caloric flavoring
intervention type: Dietary Supplement
intervention name: RTD
description: Ready to Drink Supplement
arm group label: RTD
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
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