Impact of Energy Drink Brands on Heart Rhythm

University of the Pacific

Status: Completed

Conditions: Electrical Alternation of Heart; Blood Pressure

Treatments: Other: Placebo; Dietary Supplement: Energy Drink Brand 2; Dietary Supplement: Energy Drink Brand 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03196908

17-109

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

Energy Drink Brand 1

Experimental group

Description:

Two 16-oz bottles of Energy Drink Brand 1

Treatment:

Dietary Supplement: Energy Drink Brand 1

Energy Drink Brand 2

Experimental group

Description:

Two 16-oz bottles of Energy Drink Brand 2

Treatment:

Dietary Supplement: Energy Drink Brand 2

Placebo

Placebo Comparator group

Description:

Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring

Treatment:

Other: Placebo