Blood Pressure, Electrical Alternation of Heart
Conditions
Keywords
ECG, Blood Pressure, Energy Drinks
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.
Interventions
DIETARY_SUPPLEMENTEnergy Drink Brand 1
Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
DIETARY_SUPPLEMENTEnergy Drink Brand 2
Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes
OTHERPlacebo
Lime juice, water, and cherry flavoring
Sponsors
University of the Pacific
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected QT (QTc) Interval | 4 hours | Electrocardiograph (ECG) Parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QT | 4 hours | Electrocardiograph (ECG) Parameters |
| PR | 4 hours | Electrocardiograph (ECG)Parameters |
| QRS | 4 hours | Electrocardiograph (ECG) Parameters |
| Heart Rate (HR) | 4 hours | Electrocardiograph (ECG) Parameters |
| Central blood pressure | 4 hours | Hemodynamic Parameters |
| Peripheral blood pressure | 4 hours | Hemodynamic Parameters |
Countries
United States
Outcome results
None listed