Cardiovascular Diseases
Conditions
Keywords
Energy drink, Heart rhythm, QT prolongation, Blood pressure
Brief summary
Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.
Detailed description
The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure. Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number. Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other. Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.
Interventions
OTHEREnergy drink
Two 12 oz bottles of commercially available energy drink
OTHERPlacebo drink
Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.
Sponsors
University of the Pacific
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, 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 each study day * Participants must be willing to fast 10 hours prior to each study day * Participants must have health insurance
Exclusion criteria
* Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment. * Blood pressure at initial screening appointment greater than 140/90 mmHg. * Presence of any known medical condition confirmed through participant interview * Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month) * Current smokers or those who have smoked any cigarettes within the past month * Pregnant or currently breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QTc interval | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in QTc interval from baseline in each of 2 arm |
| Central systolic blood pressure | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in central systolic blood pressure from baseline in each of 2 arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QRS duration | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in QRS duration from baseline in each of 2 arm |
| Heart rate | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in heart rate from baseline in each of 2 arm |
| QT interval | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in QT interval from baseline in each of 2 arm |
| Peripheral systolic and diastolic blood pressure | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in peripheral systolic and diastolic blood pressures in each of 2 arm |
| Augmentation index | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in augmentation index from baseline in each of 2 arm |
| Central diastolic blood pressure | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in central diastolic blood pressure from baseline in each of 2 arm |
| PR interval | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | Maximum change in PR interval from baseline in each of 2 arm |
Countries
United States
Outcome results
None listed