The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

Study Overview
=================
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.

Official Title
-----------------
The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Energy drink
* Other: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy drink<br>Two 12 oz bottles of energy drink | Other: Energy drink<br>* Two 12 oz bottles of commercially available energy drink<br>|
| Placebo Comparator: Placebo<br>Two 12 oz bottles of placebo drink | Other: Placebo drink<br>* Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval | Maximum change in QTc interval from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| Central systolic blood pressure | Maximum change in central systolic blood pressure from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT interval | Maximum change in QT interval from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| PR interval | Maximum change in PR interval from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| QRS duration | Maximum change in QRS duration from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| Heart rate | Maximum change in heart rate from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| Central diastolic blood pressure | Maximum change in central diastolic blood pressure from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| Peripheral systolic and diastolic blood pressure | Maximum change in peripheral systolic and diastolic blood pressures in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 
| Augmentation index | Maximum change in augmentation index from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy drink, Heart rhythm, QT prolongation, Blood pressure