NCT03841838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2019

Completed
Last Updated

September 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

February 12, 2019

Last Update Submit

September 23, 2019

Conditions

Cardiovascular Diseases

Keywords

Energy drinkHeart rhythmQT prolongationBlood pressure

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • QT interval

    Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours

  • PR interval

    Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours

  • QRS duration

    Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours

  • Heart rate

    Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours

  • Central diastolic blood pressure

    Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours

  • +2 more secondary outcomes

Study Arms (2)

Energy drink

EXPERIMENTAL

Two 12 oz bottles of energy drink

Other: Energy drink

Placebo

PLACEBO COMPARATOR

Two 12 oz bottles of placebo drink

Other: Placebo drink

Interventions

Energy drinkOTHER

Two 12 oz bottles of commercially available energy drink

Energy drink
Placebo drinkOTHER

Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pacific

Stockton, California, 95211, United States

Location

Related Publications (6)

  • 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.

    PMID: 28446495BACKGROUND

  • 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: 27240158BACKGROUND

  • 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: 27340146BACKGROUND

  • 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: 24644139BACKGROUND

  • 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: 26467367BACKGROUND

  • 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: 25868042BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesLong QT Syndrome

Interventions

Energy Drinks

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cynthia Lee, PharmD

    University of the Pacific

    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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

February 23, 2019

Primary Completion

May 9, 2019

Study Completion

May 9, 2019

Last Updated

September 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)