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All study drinks were presented in identical containers and were consumed over a 45‐minute period.
End points were measured on each study day at baseline (immediately prior to study drink consumption), and 1, 2, 4, 6, and 24 hours post consumption of study drink.
Caffeine has been around for centuries and is generally recognized as safe in doses less than 400 mg by the Food and Drug Administration.6 Caffeine, a natural methylxanthine, acts as a central nervous stimulant in humans by antagonizing adenosine receptors, leading to additional cardiovascular effects such as peripheral vasoconstriction and subsequent increased blood pressure (BP).7, 8 Caffeine alone is not suspected to induce any ECG changes in healthy volunteers at a dose of 400 mg.9 Typically, caffeine toxicity–related adverse events have only been observed in case studies where doses far exceed 400 mg.10, 11Although the cardiovascular safety profile of caffeine has been relatively well established, there is little published literature on the electrophysiologic and hemodynamic changes with multi‐ingredient energy drinks.
We conducted a randomized controlled trial assessing the cardiovascular safety of high‐volume energy drink consumption.
Methods and Results This was a randomized, double‐blind, controlled, crossover study in 18 young, healthy volunteers.
Participants consumed either 946 m L (32 ounces) of energy drink or caffeinated control drink, both of which contained 320 mg of caffeine, separated by a 6‐day washout period.
A significant difference in the baseline‐adjusted QTc interval (Figure 2) was evident 2 hours after energy drink consumption when compared with caffeine (0.44±18.4 ms versus −10.4±14.8 ms, respectively; =0.02).
There was no evidence of a statistically significant difference in the baseline‐adjusted HR 2 hours after energy drink consumption when compared with caffeine (3.39±11.04 versus −0.61±9.13, respectively; A significant difference in baseline‐adjusted p SBP (Figure 3) was evident 6 hours after energy drink consumption when compared with the caffeine arm (4.72±4.67 mm Hg versus 0.83±6.09 mm Hg, respectively; Adverse effects were experienced by 15 participants during the energy drink arm and by 13 participants during the caffeine control arm (Table 2).
Intention‐to‐treat analysis using the last‐observation‐carried‐forward methodology was performed to account for the missing values.Sphygmo Cor is a validated system that uses applanation tonometry to noninvasively translate a radial pressure waveform taken at the wrist to an aortic pressure waveform. Based on some of our previous data, we expected a change in the energy drink arm of 10 ms and no change in the caffeine control arm.To detect a between‐group difference of 10 ms and assuming an SD of 14 ms (2‐sided α=5% and 80% power), we would need 18 participants for the study.Nine were regular coffee drinkers (≥1 cup of coffee per day), 5 were occasional drinkers, and 4 reported no coffee consumption.
Four reported regular energy drink use (≥1 can per day), 5 occasional energy drink use, and 9 no energy drink use.The dose was based on the observation that cardiovascular adverse effects typically occur with high consumption of energy drink/caffeine.5 The amount of energy drink participants were asked to consume (2 cans totaling 320 mg caffeine) correlates to the average daily caffeine consumption (300 mg) of the US population.12 Further, nearly 15% of military personnel consume 3 cans a day in the deployed setting, which may predispose them to a higher risk threshold.5, 13 After a minimum 6‐day washout period, participants proceeded to consume the alternate study drink.Participants were required to fast for 12 hours, and abstain from any caffeinated products 48 hours prior to each study day and throughout the 24‐hour follow‐up period.Baseline QTc interval, uncorrected QT interval, PR interval, QRS duration, and HR were 413±17.3 ms, 405±26.9 ms, 158±21.0 ms, 89.1±9.69 ms, and 63.4±10.5 beats per minute, respectively.