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

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ClinicalTrials.gov Identifier: NCT03841838
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of the Pacific

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Energy drink Other: Placebo drink Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
Actual Study Start Date : February 23, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841838


Contacts
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Contact: Cynthia Lee, PharmD 2099323223 clee8@pacific.edu
Contact: Sachin Shah, PharmD sshah@pacific.edu

Locations
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United States, California
University of Pacific Recruiting
Stockton, California, United States, 95211
Contact: Cynthia Lee, PharmD         
Sponsors and Collaborators
University of the Pacific
Investigators
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Principal Investigator: Cynthia Lee, PharmD University of the Pacific

Publications:

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Responsible Party: University of the Pacific
ClinicalTrials.gov Identifier: NCT03841838     History of Changes
Other Study ID Numbers: 19-03
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of the Pacific:
Energy drink
Heart rhythm
QT prolongation
Blood pressure
Additional relevant MeSH terms:
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Cardiovascular Diseases