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

NCT03021616 | Terminated DMC

• 1 other identifier: FDG20160019H
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

energy drink; qtc interval; clotting time; thorough qt study

Outcome Measures

Primary Outcomes (12)

• QTc interval change from baseline in each of 3 arms

  1 hour post consumption

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

  1 hour post consumption

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

  1 hour post consumption

• QTc interval change from baseline in each of 3 arms

  2 hours post consumption

• QTc interval change from baseline in each of 3 arms

  4 hours post consumption

• QTc interval change from baseline in each of 3 arms

  6 hours post consumption

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

  2 hours post consumption

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

  4 hours post consumption

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

  6 hours post consumption

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

  2 hours post consumption

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

  4 hours post consumption

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

  6 hours post consumption

Secondary Outcomes (5)

• Thromboelastometry changes from baseline in each of 3 arms

  2 hours post consumption

• ECG parameter changes from baseline in each of 3 arms

  1 hour post consumption

• ECG parameter changes from baseline in each of 3 arms

  2 hours post consumption

• ECG parameter changes from baseline in each of 3 arms

  4 hours post consumption

• ECG parameter changes from baseline in each of 3 arms

  6 hours post consumption

Study Arms (3)

Energy drink

EXPERIMENTAL

Two 16 oz bottles of energy drink will be consumed at baseline.

Other: energy drink

Moxifloxacin control

ACTIVE COMPARATOR

32oz of active control drink will contain 400mg moxifloxacin with inactive flavoring ingredients.

Other: Moxifloxacin 400mg

placebo control

PLACEBO COMPARATOR

32oz placebo control drink

Other: Placebo

Interventions

energy drink OTHER

32oz of commercially available energy drink

Energy drink

Moxifloxacin 400mg OTHER

400mg moxifloxacin active control drink

Also known as: active control

Moxifloxacin control

Placebo OTHER

Placebo drink

placebo control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Related Publications (17)

• 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.

  PMID: 11310517 BACKGROUND

• 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.

  PMID: 26097791 BACKGROUND

• 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.

  PMID: 22127822 BACKGROUND

• 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.

  PMID: 26501204 BACKGROUND

• 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.

  PMID: 25868042 BACKGROUND

• 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.

  PMID: 18753650 BACKGROUND

• 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.

  PMID: 26467367 BACKGROUND

• 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.

  PMID: 25845864 BACKGROUND

• 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.

  PMID: 26444986 BACKGROUND

• 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.

  PMID: 17974021 BACKGROUND

• 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.

  PMID: 14967826 BACKGROUND

• 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.

  PMID: 26788468 BACKGROUND

• 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.

  PMID: 24644139 BACKGROUND

• 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.

  PMID: 26188956 BACKGROUND

• 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.

  PMID: 21321035 BACKGROUND

• 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.

  PMID: 27240158 BACKGROUND

• 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.

  PMID: 27340146 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Energy Drinks; Moxifloxacin

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sarah Kelly, PharmD

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 16, 2017
• Study Start: June 26, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (1)