Clinical trial NCT03841838: The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
Official title: The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Energy drink
Heart rhythm
QT prolongation
Blood pressure
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.

Detailed description: The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.

Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.

Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.

Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female adults 18-40 years old
* Participants must be willing to refrain from caffeine and alcohol use 48 hours prior to each study day
* Participants must be willing to fast 10 hours prior to each study day
* Participants must have health insurance

Exclusion Criteria:

* Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment.
* Blood pressure at initial screening appointment greater than 140/90 mmHg.
* Presence of any known medical condition confirmed through participant interview
* Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month)
* Current smokers or those who have smoked any cigarettes within the past month
* Pregnant or currently breastfeeding

Primary outcomes:
measure: QTc interval
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: Central systolic blood pressure
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary outcomes:
measure: QT interval
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: PR interval
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: QRS duration
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: Heart rate
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: Central diastolic blood pressure
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: Peripheral systolic and diastolic blood pressure
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
measure: Augmentation index
timeFrame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Other outcomes:
Locations:
city: Stockton
country: United States
facility: University of Pacific
state: California
Study officials:
affiliation: University of the Pacific
name: Cynthia Lee, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448.
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: 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: 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: 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: 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.