The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

Cardiovascular Diseases Clinical Trial

Official title:

The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841838
• Other study ID #: 19-03
• Status: Completed
• Phase: N/A
• Start date: February 23, 2019
• Est. completion date: May 9, 2019

Study information

• Verified date: March 2019
• Source: University of the Pacific
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Energy drink
Two 12 oz bottles of commercially available energy drink
• Placebo drink
Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.

Locations

Country	Name	City	State
United States	University of Pacific	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Country where clinical trial is conducted

United States, 

References & Publications (6)

Elitok A, Öz F, Panc C, Sarikaya R, Sezikli S, Pala Y, Bugan ÖS, 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. — View 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). pii: e004448. doi: 10.1161/JAHA.116.004448. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval	Maximum change in QTc interval from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Primary	Central systolic blood pressure	Maximum change in central systolic blood pressure from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	QT interval	Maximum change in QT interval from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	PR interval	Maximum change in PR interval from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	QRS duration	Maximum change in QRS duration from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	Heart rate	Maximum change in heart rate from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	Central diastolic blood pressure	Maximum change in central diastolic blood pressure from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	Peripheral systolic and diastolic blood pressure	Maximum change in peripheral systolic and diastolic blood pressures in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Secondary	Augmentation index	Maximum change in augmentation index from baseline in each of 2 arm	Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours