CompletedNot Applicable

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

United States20 participantsStarted 2019-02-23

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

QTc interval

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

Central systolic blood pressure

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

Trial details

NCT IDNCT03841838

SponsorUniversity of the Pacific

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-09

View on ClinicalTrials.gov More Cardiovascular Diseases trials