Impact of Energy Drink Brands on Heart Rhythm

December 20, 2018 updated by: University of the Pacific

Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial

To assess the cardiac effects of energy drink brands in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.

Study Type

Interventional

Enrollment (Actual)

40

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 the 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

No

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 sessions on Day 1, 8, and 15

Exclusion Criteria:

  • Presence of any known medical condition confirmed through participant interview
  • QTc interval greater than 450 milliseconds (ms).
  • Blood pressure greater than 140/90 mmHg.
  • Current smokers
  • Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
  • Pregnant or currently breast-feeding

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Energy Drink Brand 1
Two 16-oz bottles of Energy Drink Brand 1
Dietary supplement: Energy Drink Brand 1
Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
Experimental: Energy Drink Brand 2
Two 16-oz bottles of Energy Drink Brand 2
Dietary supplement: Energy Drink Brand 2
Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes
Placebo Comparator: Placebo
Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring
Other: Placebo
Lime juice, water, and cherry flavoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corrected QT (QTc) Interval
Time Frame: 4 hours
Electrocardiograph (ECG) Parameters
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT
Time Frame: 4 hours
Electrocardiograph (ECG) Parameters
4 hours
PR
Time Frame: 4 hours
Electrocardiograph (ECG)Parameters
4 hours
QRS
Time Frame: 4 hours
Electrocardiograph (ECG) Parameters
4 hours
Heart Rate (HR)
Time Frame: 4 hours
Electrocardiograph (ECG) Parameters
4 hours
Central blood pressure
Time Frame: 4 hours
Hemodynamic Parameters
4 hours
Peripheral blood pressure
Time Frame: 4 hours
Hemodynamic Parameters
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: Sachin Shah, 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)

July 1, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-109

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

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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