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OpenTrials
Completed

NCT Number: NCT03196908

Impact of Energy Drink Brands on Heart Rhythm

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

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Key information

Conditions

Electrical Alternation of Heart Blood Pressure

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Pacific

Stockton, California, 95211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy Drink Brand 1

Dietary Supplement

Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes

Energy Drink Brand 2

Dietary Supplement

Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes

Placebo

Other

Lime juice, water, and cherry flavoring

Primary outcomes

  1. Corrected QT (QTc) Interval

    Time frame: 4 hours

    Electrocardiograph (ECG) Parameters

Secondary outcomes

  1. QT

    Time frame: 4 hours

    Electrocardiograph (ECG) Parameters

  2. PR

    Time frame: 4 hours

    Electrocardiograph (ECG)Parameters

  3. QRS

    Time frame: 4 hours

    Electrocardiograph (ECG) Parameters

  4. Heart Rate (HR)

    Time frame: 4 hours

    Electrocardiograph (ECG) Parameters

  5. Central blood pressure

    Time frame: 4 hours

    Hemodynamic Parameters

  6. Peripheral blood pressure

    Time frame: 4 hours

    Hemodynamic Parameters

Sponsors and collaborators

Lead sponsor

University of the Pacific

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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