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

September 23, 2019 updated by: University of the Pacific
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stockton, California, United States, 95211
        • University of Pacific

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Energy drink
Two 12 oz bottles of energy drink
Other: Energy drink
Two 12 oz bottles of commercially available energy drink
PLACEBO_COMPARATOR: Placebo
Two 12 oz bottles of placebo drink
Other: Placebo drink
Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QTc interval
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT interval
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
PR interval
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
QRS duration
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
Heart rate
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
Central diastolic blood pressure
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
Peripheral systolic and diastolic blood pressure
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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
Augmentation index
Time Frame: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Pacific

Investigators

  • Principal Investigator: Cynthia Lee, PharmD, University of the Pacific

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 23, 2019

Primary Completion (ACTUAL)

May 9, 2019

Study Completion (ACTUAL)

May 9, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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