Impact of Energy Drink Brands on Heart Rhythm

Not Applicable

Completed

• Conditions: Blood Pressure; Electrical Alternation of Heart
• Interventions: Other: Placebo; Dietary Supplement: Energy Drink Brand 1; Dietary Supplement: Energy Drink Brand 2

• Registration Number: NCT03196908
• Lead Sponsor: University of the Pacific

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Study Start: 2017-07-01
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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
Energy Drink Brand 1	Energy Drink Brand 1	Two 16-oz bottles of Energy Drink Brand 1
Energy Drink Brand 2	Energy Drink Brand 2	Two 16-oz bottles of Energy Drink Brand 2

Primary Outcome Measures

Name	Time	Method
Corrected QT (QTc) Interval	4 hours	Electrocardiograph (ECG) Parameters

Secondary Outcome Measures

Name	Time	Method
QT	4 hours	Electrocardiograph (ECG) Parameters
Heart Rate (HR)	4 hours	Electrocardiograph (ECG) Parameters
Peripheral blood pressure	4 hours	Hemodynamic Parameters
PR	4 hours	Electrocardiograph (ECG)Parameters
Central blood pressure	4 hours	Hemodynamic Parameters
QRS	4 hours	Electrocardiograph (ECG) Parameters

Trial Locations

Locations (1)

University of the Pacific; 🇺🇸 Stockton, California, United States