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Study Title and Description

Effect of "energy drink" consumption on hemodynamic and electrocardiographic parameters in healthy young adults.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on cardiovascular outcomes?
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Primary Publication Information
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TitleData
Title Effect of "energy drink" consumption on hemodynamic and electrocardiographic parameters in healthy young adults.
Author L Steinke,DE Lanfear,V Dhanapal,JS Kalus,
Country
Year 2009
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Cardiovascular Design
Design Details
Question... Follow Up Answer Follow-up Answer
What outcome is being evaluated in this paper? Cardiovascular
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What is the objective of the study (as reported by the authors)? The purpose of this study was to evaluate the hemodynamic and ECG effects of a popular energy drink in healthy young adults.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) Design: Healthy volunteers between the ages of 18 and 40 years were enrolled. Potential subjects were excluded if they had any known medical condition, were taking any medications (including herbal products or other supplements) on a daily basis, reported regular tobacco use, or were known to be pregnant or breast-feeding. All subjects were asked to abstain from caffeine for 48 hours before the study began and were required to continue to avoid dietary sources of caffeine throughout the study period. On Day 1 of the study, subjects presented to the study center at approximately 0800, after a fast of at least 12 hours. Upon their arrival, baseline blood pressure (BP), heart rate (HR), and ECG measurements were taken. Subjects then drank 500 mL (2 cans) of an energy drink over a 30- minute period. BP, HR, and ECG were obtained again at 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours following energy drink consumption. Subjects abstained from eating or drinking anything except the assigned energy drinks over that time. Participants were then asked to consume 2 cans of the energy drink daily for each of the next 5 days, with no additional parameters measured until study Day 7. On Day 7, subjects returned to the study center in a fasting state, at approximately the same time as they had presented on Day 1. Assessment of baseline/follow-up parameters and consumption of energy drink was completed in the same manner as on Day 1. At the Day 7 visit, subjects were asked to report any adverse effects experienced during the previous 5 days. A detailed study schematic is presented in Figure 1. Energy drink studied: One can of the energy drink used in this study included 1000 mg of taurine and 100 mg of caffeine, in addition to sugars and vitamins/nutritional supplements (vitamins B5, B6, B12; glucuronolactone; niacinamide). The contents listed were obtained from the manufacturer’s ingredient list and were not verified through independent analysis. Most currently marketed energy drinks include a similar ingredient list; however, the quantities of these ingredients vary from product to product. Heart rate and blood pressure measurements: HR was calculated from the RR interval obtained from lead II of the ECG (60 sec/RR interval). BP was measured manually with a stethoscope and aneroid sphygmomanometer following 3–5 minutes of rest in a reclined position. All BP measurements for an individual subject were obtained from the same arm. Pulse pressure was calculated by subtracting diastolic BP (DBP) from systolic BP (SBP). ECG measurements: Twelve-lead ECGs were measured while the subject was resting in a supine position. Subjects were asked to not speak or cough during the test. ECGs were recorded at a paper speed of 50 mm/sec and 1 mV/cm standardization. ECGs were also obtained after the subject had at least a 3- to 5-minute period of rest. Manual measurement of intervals was carried out with a precision ruler (Schaedler Quinzel, Parsippany, NJ) as has been described previously. QTc interval was calculated with both the Bazett (QT/RR0.5) and Fridericia (QT/RR0.333) formulas.
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How many outcome-specific endpoints are evaluated? 4
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Heart rate
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List additional health endpoints (separately). 2 Blood pressure
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List additional health endpoints (separately).3 QTc interval
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List additional health endpoints (separately).4 Pulse pressure
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List additional health endpoints (separately).5
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List additional health endpoints (separately).6
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Clinical, physiological, other Physiological
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? NCT
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description HR was calculated from the RR interval obtained from lead II of the ECG (60 sec/RR interval). BP was measured manually with a stethoscope and aneroid sphygmomanometer following 3–5 minutes of rest in a reclined position. All BP measurements for an individual subject were obtained from the same arm. Pulse pressure was calculated by subtracting diastolic BP (DBP) from systolic BP (SBP). Twelve-lead ECGs were measured while the subject was resting in a supine position. Subjects were asked to not speak or cough during the test. ECGs were recorded at a paper speed of 50 mm/sec and 1 mV/cm standardization. ECGs were also obtained after the subject had at least a 3- to 5-minute period of rest. Manual measurement of intervals was carried out with a precision ruler (Schaedler Quinzel, Parsippany, NJ) as has been described previously. QTc interval was calculated with both the Bazett (QT/RR0.5) and Fridericia (QT/RR0.333) formulas.
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Caffeine (general)
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Coffee, Chocolate, energy drink, gum, medicine/supplement, soda, tea, other? Energy drinks
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Measured or self reported? Measured
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Children, adolescents, adults, or pregnant included? Adults
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Subjects served as their own baseline.
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) Potential subjects were excluded if they had any known medical condition, were taking any medications (including herbal products or other supplements) on a daily basis, reported regular tobacco use, or were known to be pregnant or breast-feeding. Continuous data are presented as mean ± SD. Categorical data are presented as proportions. Baseline BP, HR, and ECG measurements were compared with maximum measurements obtained on the same study day with a paired t-test. At each time-point, Day 1 measurements were compared with Day 7 measurements with a paired t-test as well.
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What conflicts of interest were reported? Conflicts were not mentioned.
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Refid 19299320
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What were the sources of funding? "Funding for this study was provided by the Undergraduate Research and Creative Projects Grant, Wayne State University, Detroit, MI."
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Results & Comparisons

No Results found.