Impact of Energy Drink Brands on Heart Rhythm

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196908
• Other study ID #: 17-109
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2018
• Source: University of the Pacific
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Electrical Alternation of Heart

Intervention

Dietary Supplement:
• Energy Drink Brand 1
Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
• Energy Drink Brand 2
Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes

Other:
• Placebo
Lime juice, water, and cherry flavoring

Locations

Country	Name	City	State
United States	University of the Pacific	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected QT (QTc) Interval	Electrocardiograph (ECG) Parameters	4 hours
Secondary	QT	Electrocardiograph (ECG) Parameters	4 hours
Secondary	PR	Electrocardiograph (ECG)Parameters	4 hours
Secondary	QRS	Electrocardiograph (ECG) Parameters	4 hours
Secondary	Heart Rate (HR)	Electrocardiograph (ECG) Parameters	4 hours
Secondary	Central blood pressure	Hemodynamic Parameters	4 hours
Secondary	Peripheral blood pressure	Hemodynamic Parameters	4 hours