<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/NCT03021616</url>
  </required_header>
  <id_info>
    <org_study_id>FDG20160019H</org_study_id>
    <nct_id>NCT03021616</nct_id>
  </id_info>
  <brief_title>Evaluation of Energy Drinks on Electrocardiographic, Vascular and Hematologic Parameters in Healthy Volunteers</brief_title>
  <official_title>Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers: A Randomized, Double Blind, Active-Controlled, Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Grant U.S. Air Force Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>David Grant U.S. Air Force Medical Center</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 determine the cardiovascular effects of energy drink consumption in healthy&#xD;
      individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®&#xD;
      analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blind, controlled, crossover study evaluating the&#xD;
      electrocardiographic, blood pressure, and hematological effects of an energy drink.&#xD;
&#xD;
        -  Subjects who have contacted the PI/AI/SC for consideration of participation in this&#xD;
           study will be scheduled a time to come to the Clinical Investigation Facility (CIF)&#xD;
           Interview Room, which is a private room located on the David Grant Medical Center&#xD;
           campus, for an initial evaluation for inclusion eligibility determination.&#xD;
&#xD;
        -  At the initial evaluation subjects will be informed about the details of the study, be&#xD;
           presented with the Informed Consent Document (ICD) and HIPAA documents and be asked to&#xD;
           sign the appropriate forms voluntarily if they want to be a part of this study. Once&#xD;
           consented, subjects will then be asked a series of questions to see if they qualify for&#xD;
           inclusion in the study. A baseline ECG, Chem 7, and a peripheral blood pressure will be&#xD;
           obtained to rule out everything but normal sinus rhythm, normal potassium level, and&#xD;
           blood pressure less than 140/90. A cardiologist will approve every baseline ECG to allow&#xD;
           the participant to enroll in the study.&#xD;
&#xD;
        -  If the subject meets inclusion criteria and are approved by the cardiologist, they will&#xD;
           be enrolled, and allocated a randomized participant ID number. They will also be given&#xD;
           the &quot;Participant Instruction Sheet&quot;.&#xD;
&#xD;
        -  Participants will be asked to document their normal baseline caffeine consumption on the&#xD;
           initial questionnaire.&#xD;
&#xD;
        -  Participants will randomly be assigned to consume either two-16 oz. containers of&#xD;
           Monster Energy® drink, original flavor, two-16 oz. containers of an active control&#xD;
           drink, or two 16 oz. containers of a placebo drink during their first day of treatment.&#xD;
&#xD;
        -  The blinding and randomization will be performed by a member of the pharmacy staff who&#xD;
           will have the randomization code in a sealed envelope in the pharmacy. The PI, AIs and&#xD;
           SC will be blinded. In the event of a medical emergency, unblinding a particular subject&#xD;
           may occur upon request to the pharmacy staff from an investigator or study coordinator.&#xD;
           Only the requested subject will be unblinded.&#xD;
&#xD;
        -  The control drinks will comprise an equivalent volume. The active control drink 16 oz.&#xD;
           bottle will contain: 200 mg moxifloxacin (dissolved tablet), carbonated water,&#xD;
           reconstituted lime juice (readily available from supermarkets), and cherry flavoring&#xD;
           (regularly used flavoring in compounding). The placebo drink will be the same except it&#xD;
           will not contain moxifloxacin.&#xD;
&#xD;
        -  The energy drink and control drinks will be repackaged by a member of the pharmacy staff&#xD;
           in identical 16 oz. bottles and checked by another staff member. The active and control&#xD;
           drinks will be made at least 24 hours but no more than 7 days in advance and will be&#xD;
           stored in a refrigerator in a designated area within the inpatient pharmacy. Study&#xD;
           drinks will be available for the investigator/coordinator for distribution to the&#xD;
           participants.&#xD;
&#xD;
        -  Participants will be informed on the &quot;Participant Instruction Sheet&quot; to refrain from&#xD;
           caffeine or energy drink consumption for 48 hours prior to study days 1, 8, and 15. They&#xD;
           will need to have similar work shifts 48 hours before each study day (i.e. day or night&#xD;
           shift). In addition, participants will be instructed to be in the fasting state (no food&#xD;
           or drink other than water) for 12 hours prior to study days 1, 8, and 15.&#xD;
&#xD;
        -  On day 1, a baseline ECG, HR, peripheral and central blood pressures, and lab draw will&#xD;
           be obtained prior to consumption of the assigned study drink. The lab draw will be used&#xD;
           to determine baseline clotting time using ROTEM® analysis. After completion of baseline&#xD;
           readings, subjects will have 45 minutes to consume two-16 oz. containers of Monster&#xD;
           Energy® or either control drink as assigned. The time clock for study duration will&#xD;
           start when the participant is issued their study drink. Repeat measurements of ECG, HR,&#xD;
           peripheral and central blood pressures will be performed at 1, 2, 4, and 6 hours. In&#xD;
           addition, a second lab draw will be taken at 2 hours and submitted for ROTEM® analysis&#xD;
           to determine clotting time. At 2 hours the subject will also be provided a&#xD;
           study-controlled breakfast. During each measurement session, participants will also be&#xD;
           asked to &quot;describe any adverse effects you may be experiencing&quot;. All measurements taken&#xD;
           and responses from participants will be annotated on the participant treatment form.&#xD;
&#xD;
        -  Participants may eat after lunch between hours four and five after the energy drink was&#xD;
           consumed. They will be asked to eat approximately the same meals for lunch on the 3&#xD;
           study days. They may not consume additional caffeine or energy drinks not provided by&#xD;
           the study group until after the measurements are taken 6 hours later.&#xD;
&#xD;
        -  A minimum 6-day wash-out period must elapse prior to initiation of the second phase of&#xD;
           the study, at which time the same treatment/monitoring process will occur (i.e. Day 8 or&#xD;
           after). It will again be repeated on day 15 or after.&#xD;
&#xD;
        -  Measurements will include: ECG, BP, lab draw, and questions about side effects each&#xD;
           participant may be experiencing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Results from sister study at University of the Pacific were conclusive.&#xD;
  </why_stopped>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QTc interval change from baseline in each of 3 arms</measure>
    <time_frame>1 hour post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Central systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>1 hour post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>1 hour post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>QTc interval change from baseline in each of 3 arms</measure>
    <time_frame>2 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>QTc interval change from baseline in each of 3 arms</measure>
    <time_frame>4 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>QTc interval change from baseline in each of 3 arms</measure>
    <time_frame>6 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>central systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>2 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>central systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>4 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>central systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>6 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>2 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>4 hours post consumption</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral systolic blood pressure change from baseline in each of 3 arms</measure>
    <time_frame>6 hours post consumption</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thromboelastometry changes from baseline in each of 3 arms</measure>
    <time_frame>2 hours post consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG parameter changes from baseline in each of 3 arms</measure>
    <time_frame>1 hour post consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG parameter changes from baseline in each of 3 arms</measure>
    <time_frame>2 hours post consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG parameter changes from baseline in each of 3 arms</measure>
    <time_frame>4 hours post consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG parameter changes from baseline in each of 3 arms</measure>
    <time_frame>6 hours post consumption</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Energy drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two 16 oz bottles of energy drink will be consumed at baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>32oz of active control drink will contain 400mg moxifloxacin with inactive flavoring ingredients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>32oz placebo control drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>energy drink</intervention_name>
    <description>32oz of commercially available energy drink</description>
    <arm_group_label>Energy drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moxifloxacin 400mg</intervention_name>
    <description>400mg moxifloxacin active control drink</description>
    <arm_group_label>Moxifloxacin control</arm_group_label>
    <other_name>active control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo drink</description>
    <arm_group_label>placebo control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female, active duty military service members or DoD beneficiaries,&#xD;
             who are eligible to receive care at DGMC.&#xD;
&#xD;
          -  Ages 18-40 years old.&#xD;
&#xD;
          -  Participants must be willing to refrain from caffeine and energy drink use 48 hours&#xD;
             prior to study days 1, 8, and 15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In an effort to recruit subjects in general good health, those with the following&#xD;
             medical conditions or disease states will be excluded from enrollment:&#xD;
&#xD;
               -  Cardiovascular risk factors: Heart rhythm other than normal sinus, history of&#xD;
                  atrial or ventricular arrhythmia, family history of premature sudden cardiac&#xD;
                  death before the age of 60, left ventricular hypertrophy, acute myocardial&#xD;
                  ischemia, atherosclerosis, hypertension, palpitations, T-wave abnormalities,&#xD;
                  baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will&#xD;
                  be determined on the ECG obtained during initial screening appointment, and&#xD;
                  reviewed by cardiologist and through the questionnaire responses of the&#xD;
                  participant.&#xD;
&#xD;
               -  Blood pressure at initial screening appointment or at baseline on study Day 1&#xD;
                  greater than 140/90&#xD;
&#xD;
               -  Hypokalemia or liver abnormalities (AST/ALT abnormality) identified at initial&#xD;
                  appointment when baseline lab values will be drawn.&#xD;
&#xD;
               -  Presence of any known medical condition, confirmed through participant interview&#xD;
                  up to the discretion of the research team. Examples of these are:&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  Recurrent headaches&#xD;
&#xD;
          -  Depression, currently receiving treatment (due to possible drug interactions)&#xD;
&#xD;
          -  Any psychiatric condition or neurological disorder including seizures&#xD;
&#xD;
          -  History of alcohol or drug abuse in the previous 5 years&#xD;
&#xD;
          -  Ever been diagnosed or told they have or had renal or hepatic dysfunction&#xD;
&#xD;
               -  Concurrent use of ANY medication taken in an amount greater than twice a week, to&#xD;
                  include herbal products or supplements, NOT TO INCLUDE hormonal contraceptives.&#xD;
                  If less than or equal to 2 days per week, the investigator will determine if the&#xD;
                  subject is to be included or excluded based on the available literature for that&#xD;
                  medication.&#xD;
&#xD;
               -  Pregnant or lactating females will be excluded from participation with urine&#xD;
                  dipstick tests used to confirm pregnancy (pregnancy test performed before each&#xD;
                  treatment session, days 1, 8 and 15)&#xD;
&#xD;
               -  All non-English speaking / writing subjects and those that do not understand the&#xD;
                  study or consent process will be excluded from the study due to unavailability of&#xD;
                  medical qualified translator at all times during the study.&#xD;
&#xD;
               -  If the subject refuses to sign the informed consent document or HIPAA&#xD;
                  Authorization, they will be excluded as well.&#xD;
&#xD;
               -  Allergy to any substance in the study design.&#xD;
&#xD;
               -  Any other medical reason that at the discretion of the investigators would pose a&#xD;
                  risk to the health of the subject.&#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>Sarah Kelly, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>David Grant Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David Grant Medical Center</name>
      <address>
        <city>Travis Air Force Base</city>
        <state>California</state>
        <zip>94535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ammar R, Song JC, Kluger J, White CM. Evaluation of electrocardiographic and hemodynamic effects of caffeine with acute dosing in healthy volunteers. Pharmacotherapy. 2001 Apr;21(4):437-42. doi: 10.1592/phco.21.5.437.34502.</citation>
    <PMID>11310517</PMID>
  </reference>
  <reference>
    <citation>Biewenga J, Keung C, Solanki B, Natarajan J, Leitz G, Deleu S, Soons P. Absence of QTc Prolongation with Domperidone: A Randomized, Double-Blind, Placebo- and Positive-Controlled Thorough QT/QTc Study in Healthy Volunteers. Clin Pharmacol Drug Dev. 2015 Jan;4(1):41-48. doi: 10.1002/cpdd.126. Epub 2014 May 30.</citation>
    <PMID>26097791</PMID>
  </reference>
  <reference>
    <citation>Carlson GF, Tou CK, Parikh S, Birmingham BK, Butler K. Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study. Diabetes Ther. 2011 Sep;2(3):123-32. doi: 10.1007/s13300-011-0003-2. Epub 2011 Jun 24.</citation>
    <PMID>22127822</PMID>
  </reference>
  <reference>
    <citation>Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Nov;53(11):963-71. doi: 10.5414/CP202457.</citation>
    <PMID>26501204</PMID>
  </reference>
  <reference>
    <citation>Elitok A, Oz F, Panc C, Sarikaya R, Sezikli S, Pala Y, Bugan OS, Ates M, Parildar H, Ayaz MB, Atici A, Oflaz H. Acute effects of Red Bull energy drink on ventricular repolarization in healthy young volunteers: a prospective study. Anatol J Cardiol. 2015 Nov;15(11):919-22. doi: 10.5152/akd.2015.5791. Epub 2015 Mar 5.</citation>
    <PMID>25868042</PMID>
  </reference>
  <reference>
    <citation>Furie B, Furie BC. Mechanisms of thrombus formation. N Engl J Med. 2008 Aug 28;359(9):938-49. doi: 10.1056/NEJMra0801082. No abstract available.</citation>
    <PMID>18753650</PMID>
  </reference>
  <reference>
    <citation>Hajsadeghi S, Mohammadpour F, Manteghi MJ, Kordshakeri K, Tokazebani M, Rahmani E, Hassanzadeh M. Effects of energy drinks on blood pressure, heart rate, and electrocardiographic parameters: An experimental study on healthy young adults. Anatol J Cardiol. 2016 Feb;16(2):94-9. doi: 10.5152/akd.2015.5930. Epub 2015 Mar 23.</citation>
    <PMID>26467367</PMID>
  </reference>
  <reference>
    <citation>Litwin JS, Benedict MS, Thorn MD, Lawrence LE, Cammarata SK, Sun E. A thorough QT study to evaluate the effects of therapeutic and supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother. 2015;59(6):3469-73. doi: 10.1128/AAC.04813-14. Epub 2015 Apr 6.</citation>
    <PMID>25845864</PMID>
  </reference>
  <reference>
    <citation>Kumagai Y, Hasunuma T, Sakai S, Ochiai H, Samukawa Y. Randomized, Controlled, Thorough QT/QTc Study Shows Absence of QT Prolongation with Luseogliflozin in Healthy Japanese Subjects. PLoS One. 2015 Oct 7;10(10):e0139873. doi: 10.1371/journal.pone.0139873. eCollection 2015.</citation>
    <PMID>26444986</PMID>
  </reference>
  <reference>
    <citation>Malinauskas BM, Aeby VG, Overton RF, Carpenter-Aeby T, Barber-Heidal K. A survey of energy drink consumption patterns among college students. Nutr J. 2007 Oct 31;6:35. doi: 10.1186/1475-2891-6-35.</citation>
    <PMID>17974021</PMID>
  </reference>
  <reference>
    <citation>Myers MG. Effect of caffeine on blood pressure beyond the laboratory. Hypertension. 2004 Apr;43(4):724-5. doi: 10.1161/01.HYP.0000120970.49340.33. Epub 2004 Feb 16. No abstract available.</citation>
    <PMID>14967826</PMID>
  </reference>
  <reference>
    <citation>Ohno Y, Kanno Y, Takenaka T. Central blood pressure and chronic kidney disease. World J Nephrol. 2016 Jan 6;5(1):90-100. doi: 10.5527/wjn.v5.i1.90.</citation>
    <PMID>26788468</PMID>
  </reference>
  <reference>
    <citation>Phan JK, Shah SA. Effect of caffeinated versus noncaffeinated energy drinks on central blood pressures. Pharmacotherapy. 2014 Jun;34(6):555-60. doi: 10.1002/phar.1419. Epub 2014 Mar 19.</citation>
    <PMID>24644139</PMID>
  </reference>
  <reference>
    <citation>Pommerening MJ, Cardenas JC, Radwan ZA, Wade CE, Holcomb JB, Cotton BA. Hypercoagulability after energy drink consumption. J Surg Res. 2015 Dec;199(2):635-40. doi: 10.1016/j.jss.2015.06.027. Epub 2015 Jun 18.</citation>
    <PMID>26188956</PMID>
  </reference>
  <reference>
    <citation>Seifert SM, Schaechter JL, Hershorin ER, Lipshultz SE. Health effects of energy drinks on children, adolescents, and young adults. Pediatrics. 2011 Mar;127(3):511-28. doi: 10.1542/peds.2009-3592. Epub 2011 Feb 14. Erratum In: Pediatrics. 2016 May;137(5):null.</citation>
    <PMID>21321035</PMID>
  </reference>
  <reference>
    <citation>Shah SA, Occiano A, Nguyen TA, Chan A, Sky JC, Bhattacharyya M, O'Dell KM, Shek A, Nguyen NN. Electrocardiographic and blood pressure effects of energy drinks and Panax ginseng in healthy volunteers: A randomized clinical trial. Int J Cardiol. 2016 Sep 1;218:318-323. doi: 10.1016/j.ijcard.2016.05.007. Epub 2016 May 13.</citation>
    <PMID>27240158</PMID>
  </reference>
  <reference>
    <citation>Shah SA, Chu BW, Lacey CS, Riddock IC, Lee M, Dargush AE. Impact of Acute Energy Drink Consumption on Blood Pressure Parameters: A Meta-analysis. Ann Pharmacother. 2016 Oct;50(10):808-15. doi: 10.1177/1060028016656433. Epub 2016 Jun 23.</citation>
    <PMID>27340146</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>energy drink</keyword>
  <keyword>qtc interval</keyword>
  <keyword>clotting time</keyword>
  <keyword>thorough qt study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03021616
org study id: FDG20160019H
nct id: NCT03021616
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will determine the cardiovascular effects of energy drink consumption in healthy
      individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®
      analysis.
This is a randomized, double blind, controlled, crossover study evaluating the
      electrocardiographic, blood pressure, and hematological effects of an energy drink.

        -  Subjects who have contacted the PI/AI/SC for consideration of participation in this
           study will be scheduled a time to come to the Clinical Investigation Facility (CIF)
           Interview Room, which is a private room located on the David Grant Medical Center
           campus, for an initial evaluation for inclusion eligibility determination.

        -  At the initial evaluation subjects will be informed about the details of the study, be
           presented with the Informed Consent Document (ICD) and HIPAA documents and be asked to
           sign the appropriate forms voluntarily if they want to be a part of this study. Once
           consented, subjects will then be asked a series of questions to see if they qualify for
           inclusion in the study. A baseline ECG, Chem 7, and a peripheral blood pressure will be
           obtained to rule out everything but normal sinus rhythm, normal potassium level, and
           blood pressure less than 140/90. A cardiologist will approve every baseline ECG to allow
           the participant to enroll in the study.

        -  If the subject meets inclusion criteria and are approved by the cardiologist, they will
           be enrolled, and allocated a randomized participant ID number. They will also be given
           the "Participant Instruction Sheet".

        -  Participants will be asked to document their normal baseline caffeine consumption on the
           initial questionnaire.

        -  Participants will randomly be assigned to consume either two-16 oz. containers of
           Monster Energy® drink, original flavor, two-16 oz. containers of an active control
           drink, or two 16 oz. containers of a placebo drink during their first day of treatment.

        -  The blinding and randomization will be performed by a member of the pharmacy staff who
           will have the randomization code in a sealed envelope in the pharmacy. The PI, AIs and
           SC will be blinded. In the event of a medical emergency, unblinding a particular subject
           may occur upon request to the pharmacy staff from an investigator or study coordinator.
           Only the requested subject will be unblinded.

        -  The control drinks will comprise an equivalent volume. The active control drink 16 oz.
           bottle will contain: 200 mg moxifloxacin (dissolved tablet), carbonated water,
           reconstituted lime juice (readily available from supermarkets), and cherry flavoring
           (regularly used flavoring in compounding). The placebo drink will be the same except it
           will not contain moxifloxacin.

        -  The energy drink and control drinks will be repackaged by a member of the pharmacy staff
           in identical 16 oz. bottles and checked by another staff member. The active and control
           drinks will be made at least 24 hours but no more than 7 days in advance and will be
           stored in a refrigerator in a designated area within the inpatient pharmacy. Study
           drinks will be available for the investigator/coordinator for distribution to the
           participants.

        -  Participants will be informed on the "Participant Instruction Sheet" to refrain from
           caffeine or energy drink consumption for 48 hours prior to study days 1, 8, and 15. They
           will need to have similar work shifts 48 hours before each study day (i.e. day or night
           shift). In addition, participants will be instructed to be in the fasting state (no food
           or drink other than water) for 12 hours prior to study days 1, 8, and 15.

        -  On day 1, a baseline ECG, HR, peripheral and central blood pressures, and lab draw will
           be obtained prior to consumption of the assigned study drink. The lab draw will be used
           to determine baseline clotting time using ROTEM® analysis. After completion of baseline
           readings, subjects will have 45 minutes to consume two-16 oz. containers of Monster
           Energy® or either control drink as assigned. The time clock for study duration will
           start when the participant is issued their study drink. Repeat measurements of ECG, HR,
           peripheral and central blood pressures will be performed at 1, 2, 4, and 6 hours. In
           addition, a second lab draw will be taken at 2 hours and submitted for ROTEM® analysis
           to determine clotting time. At 2 hours the subject will also be provided a
           study-controlled breakfast. During each measurement session, participants will also be
           asked to "describe any adverse effects you may be experiencing". All measurements taken
           and responses from participants will be annotated on the participant treatment form.

        -  Participants may eat after lunch between hours four and five after the energy drink was
           consumed. They will be asked to eat approximately the same meals for lunch on the 3
           study days. They may not consume additional caffeine or energy drinks not provided by
           the study group until after the measurements are taken 6 hours later.

        -  A minimum 6-day wash-out period must elapse prior to initiation of the second phase of
           the study, at which time the same treatment/monitoring process will occur (i.e. Day 8 or
           after). It will again be repeated on day 15 or after.

        -  Measurements will include: ECG, BP, lab draw, and questions about side effects each
           participant may be experiencing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: QTc interval change from baseline in each of 3 arms
time frame: 1 hour post consumption
measure: Central systolic blood pressure change from baseline in each of 3 arms
time frame: 1 hour post consumption
measure: Peripheral systolic blood pressure change from baseline in each of 3 arms
time frame: 1 hour post consumption
measure: QTc interval change from baseline in each of 3 arms
time frame: 2 hours post consumption
measure: QTc interval change from baseline in each of 3 arms
time frame: 4 hours post consumption
measure: QTc interval change from baseline in each of 3 arms
time frame: 6 hours post consumption
measure: central systolic blood pressure change from baseline in each of 3 arms
time frame: 2 hours post consumption
measure: central systolic blood pressure change from baseline in each of 3 arms
time frame: 4 hours post consumption
measure: central systolic blood pressure change from baseline in each of 3 arms
time frame: 6 hours post consumption
measure: Peripheral systolic blood pressure change from baseline in each of 3 arms
time frame: 2 hours post consumption
measure: Peripheral systolic blood pressure change from baseline in each of 3 arms
time frame: 4 hours post consumption
measure: Peripheral systolic blood pressure change from baseline in each of 3 arms
time frame: 6 hours post consumption
measure: Thromboelastometry changes from baseline in each of 3 arms
time frame: 2 hours post consumption
measure: ECG parameter changes from baseline in each of 3 arms
time frame: 1 hour post consumption
measure: ECG parameter changes from baseline in each of 3 arms
time frame: 2 hours post consumption
measure: ECG parameter changes from baseline in each of 3 arms
time frame: 4 hours post consumption
measure: ECG parameter changes from baseline in each of 3 arms
time frame: 6 hours post consumption
arm group label: Energy drink
arm group type: Experimental
description: Two 16 oz bottles of energy drink will be consumed at baseline.
arm group label: Moxifloxacin control
arm group type: Active Comparator
description: 32oz of active control drink will contain 400mg moxifloxacin with inactive flavoring ingredients.
arm group label: placebo control
arm group type: Placebo Comparator
description: 32oz placebo control drink
intervention type: Other
intervention name: energy drink
description: 32oz of commercially available energy drink
arm group label: Energy drink
intervention type: Other
intervention name: Moxifloxacin 400mg
description: 400mg moxifloxacin active control drink
arm group label: Moxifloxacin control
other name: active control
intervention type: Other
intervention name: Placebo
description: Placebo drink
arm group label: placebo control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Kelly, PharmD
role: Principal Investigator
affiliation: David Grant Medical Center
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Moxifloxacin