Impact of Energy Drink Brands on Heart Rhythm

N/ACompletedNCT03196908

University of the Pacific40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Electrical Alternation of Heart Blood Pressure

Interventions

Energy Drink Brand 1DIETARY_SUPPLEMENT

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

Energy Drink Brand 2DIETARY_SUPPLEMENT

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

PlaceboOTHER

Lime juice, water, and cherry flavoring

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of the Pacific

Stockton, California, United States

Outcomes

Primary Outcomes

Corrected QT (QTc) Interval

Electrocardiograph (ECG) Parameters

Time frame: 4 hours

Secondary Outcomes

Electrocardiograph (ECG) Parameters

Time frame: 4 hours

Electrocardiograph (ECG)Parameters

Time frame: 4 hours

QRS

Electrocardiograph (ECG) Parameters

Time frame: 4 hours

Heart Rate (HR)

Electrocardiograph (ECG) Parameters

Time frame: 4 hours

Central blood pressure

Hemodynamic Parameters

Time frame: 4 hours

Peripheral blood pressure

Hemodynamic Parameters

Time frame: 4 hours

Data from ClinicalTrials.gov

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