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Cardiovascular DiseasesNCT03021616

Evaluation of Energy Drinks on Electrocardiographic, Vascular and Hematologic Parameters in Healthy Volunteers

A study testing energy drink and Moxifloxacin 400mg in people with Cardiovascular Diseases, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will determine the cardiovascular effects of energy drink consumption in healthy individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM® analysis. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
energy drink and Moxifloxacin 400mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteUnited States
Study dates
26 Jun 2017to 13 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
  • Ages 18-40 years old.
  • Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1, 8, and 15

Who cannot join

  • In an effort to recruit subjects in general good health, those with the following medical conditions or disease states will be excluded from enrollment:
  • Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
  • Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
  • Hypokalemia or liver abnormalities (AST/ALT abnormality) identified at initial appointment when baseline lab values will be drawn.
  • Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
  • Hypertension
Show all 19Show fewer
  • Thyroid disease
  • Type 1 or 2 diabetes mellitus
  • Recurrent headaches
  • Depression, currently receiving treatment (due to possible drug interactions)
  • Any psychiatric condition or neurological disorder including seizures
  • History of alcohol or drug abuse in the previous 5 years
  • Ever been diagnosed or told they have or had renal or hepatic dysfunction
  • Concurrent use of ANY medication taken in an amount greater than twice a week, to include herbal products or supplements, NOT TO INCLUDE hormonal contraceptives. If less than or equal to 2 days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
  • Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1, 8 and 15)
  • All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
  • If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.
  • Allergy to any substance in the study design.
  • Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

Other trials in United States

About this study

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

This study will determine the cardiovascular effects of energy drink consumption in healthy individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM® analysis.

Read the detailed description

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.
Being tested
energy drink, Moxifloxacin 400mg, Placebo
Keywords
energy drink, qtc interval, clotting time, thorough qt study
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • energy drinkOther

    32oz of commercially available energy drink

  • Moxifloxacin 400mgOther

    Also called active control

    400mg moxifloxacin active control drink

  • PlaceboOther

    Placebo drink

Study groups in NCT03021616
Study groupRoleWhat they receive
Energy drinkExperimentalTwo 16 oz bottles of energy drink will be consumed at baseline.
Receives: Other: energy drink
Moxifloxacin controlActive comparator32oz of active control drink will contain 400mg moxifloxacin with inactive flavoring ingredients.
Receives: Other: Moxifloxacin 400mg
placebo controlPlacebo comparator32oz placebo control drink
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QTc interval change from baseline in each of 3 arms

    Measured: 1 hour post consumption

  2. Central systolic blood pressure change from baseline in each of 3 arms

    Measured: 1 hour post consumption

  3. Peripheral systolic blood pressure change from baseline in each of 3 arms

    Measured: 1 hour post consumption

  4. QTc interval change from baseline in each of 3 arms

    Measured: 2 hours post consumption

  5. QTc interval change from baseline in each of 3 arms

    Measured: 4 hours post consumption

  6. QTc interval change from baseline in each of 3 arms

    Measured: 6 hours post consumption

  7. central systolic blood pressure change from baseline in each of 3 arms

    Measured: 2 hours post consumption

  8. central systolic blood pressure change from baseline in each of 3 arms

    Measured: 4 hours post consumption

  9. central systolic blood pressure change from baseline in each of 3 arms

    Measured: 6 hours post consumption

  10. Peripheral systolic blood pressure change from baseline in each of 3 arms

    Measured: 2 hours post consumption

  11. Peripheral systolic blood pressure change from baseline in each of 3 arms

    Measured: 4 hours post consumption

  12. Peripheral systolic blood pressure change from baseline in each of 3 arms

    Measured: 6 hours post consumption

Secondary outcomes (5)

  1. Thromboelastometry changes from baseline in each of 3 arms

    Measured: 2 hours post consumption

  2. ECG parameter changes from baseline in each of 3 arms

    Measured: 1 hour post consumption

  3. ECG parameter changes from baseline in each of 3 arms

    Measured: 2 hours post consumption

  4. ECG parameter changes from baseline in each of 3 arms

    Measured: 4 hours post consumption

  5. ECG parameter changes from baseline in each of 3 arms

    Measured: 6 hours post consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2017 (estimated)
  2. Study start26 Jun 2017
  3. Primary completion13 Mar 2018
  4. Study completion13 Mar 2018

Why it stopped: Results from sister study at University of the Pacific were conclusive.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03021616
Sponsor's protocol ID
FDG20160019H
Status last verified
Apr 2020
First submitted
11 Jan 2017
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 11310517

  • 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.

    PubMed 26097791

  • 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.

    PubMed 22127822

  • 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.

    PubMed 26501204

  • 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.

    PubMed 25868042

  • 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.

    PubMed 18753650

  • 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.

    PubMed 26467367

  • 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.

    PubMed 25845864

  • 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.

    PubMed 26444986

  • 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.

    PubMed 17974021

  • 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.

    PubMed 14967826

  • 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.

    PubMed 26788468

  • 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.

    PubMed 24644139

  • 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.

    PubMed 26188956

  • 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.

    PubMed 21321035

Questions about this trial

What is this clinical trial studying?

A study testing energy drink and Moxifloxacin 400mg in people with Cardiovascular Diseases, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Results from sister study at University of the Pacific were conclusive.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QTc interval change from baseline in each of 3 arms (time frame: 1 hour post consumption). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021616, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.

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