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Study Title and Description

Subjective state, blood pressure, and behavioral control changes produced by an "energy shot"



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 Subjective state, blood pressure, and behavioral control changes produced by an "energy shot"
Author C. A. Marczinski, A. L. Stamates, J. Ossege, S. F. Maloney, M. E. Bardgett and C. J. Brown
Country
Year 2014
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 investigate the acute effects of a popular energy shot (5-Hour Energy) on subjective and objective measures that were assessed hourly for 6 hours following consumption.
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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) Participants Individuals were recruited for this study using posters that were displayed around Northern Kentucky University. Potential volunteers completed questionnaires that provided demographic information and physical and mental health status. Any individual who self-reported a psychiatric disorder, substance abuse disorder, or head injury was excluded. All participants were tested for recent use of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methamphetamine, opiates, and tetrahydrocannabinol by urinalysis at the start of each session. If any individual had tested positive for any of these drugs, they would have been excluded from the study. No females who were pregnant or breast-feeding participated, as determined by both self-report and urine human chorionic gonadotropin (HCG) levels. Eligibility requirements included being at least 18 years of age, having a body mass index (BMI) in the normal range (< 25), having consumed at least one energy drink in the past year, and having consumed at least one caffeinated beverage in the past 2 weeks. Fourteen healthy individuals (7 males) between the ages of 18 and 29 years were recruited to participate in the study. The majority of participants (64%) had tried 5-Hour Energy at least once. Procedure Eligible volunteers were scheduled for three separate sessions (separated by a minimum of 24 hours and session start times beginning at approximately 10 a.m.). Session start times did not deviate by more than 1 hour for each individual subject. Before each session, participants were required to fast for 2 hours, abstain from caffeine for 8 hours, and abstain from alcohol for 24 hours. Any subject that failed to follow these instructions, as measured by their responses to a dietary questionnaire at the start of each session, was rescheduled. This only occurred on twice for the entire study, and the participant was rescheduled for testing the next day. Upon arrival in the laboratory, participants provided informed consent and were assigned to the dose order for the three-session study. Dose administration for this study was double-blind, and dose order was counterbalanced between subjects. The three dose conditions included a 2 oz 5-Hour Energy shot, 2 oz. Ocean Spray Diet Cranberry Juice as the placebo, or no drink. The energy shot chosen (in berry flavor) is the market leader in the category and is sold in vending machines on the campus. The manufacturer’s Web site reports that each bottle contains 200mg of caffeine (www.5hourenergy.com), an amount of caffeine that is similar to a strong cup of coffee. The placebo was chosen based on similarity in taste and color to the energy shot. Both the energy shot and placebo are sugar free. The no drink control condition was included to control for expectancy effects. Participants were tested individually by a research assistant. All testing was conducted in a small room that consisted of a chair and desk with a laptop computer On the first session only, participants completed a medical history form, the caffeine use questionnaire, and were weighed. Before dose administration on all three sessions, blood pressure and pulse rate were recorded using a Medline Automatic Blood Pressure Monitor (Medline Industries, Inc., Mundelein, IL) to ensure that normal blood pressure (i.e., below 120/80mm Hg). Participants then received their beverage (if assigned) in a small plastic cup and were informed that the drink should be consumed in less than a minute. Exact contents of the beverages were never disclosed to participants. Participants rested for 30 minutes before the onset of testing. Starting at 30 minutes following dose administration, the testing battery began (consisting of subjective Profile of Mood States [PMOS} and a cued go/no-go task). Blood pressure and pulse rate were recorded at 60, 120, 180, 240, 300, and 360 minutes after dose administration. When participants were not completing the task, questionnaires, or giving blood pressure readings, they were offered magazines to read during periods of rest. Upon completion of the third session, participants were debriefed and released. They received their compensation ($100) by check in the mail. Criterion measures and data analyses Blood pressure (systolic and diastolic) and pulse rate recordings were analyzed by a 3 x 6 (Dose: energy shot, placebo, no drink x Time: 60, 120, 180, 240, 300, 360 minutes) within-subjects analysis of variance (ANOVA). When overall ANOVAs required post-hoc testing, the least significant difference (LSD) test was utilized. All statistical analyses were performed using SPSS v18.0 (IBM Corp., Armonk, NY) with level of significance set at 0.05 for all statistical tests
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How many outcome-specific endpoints are evaluated? 2
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Blood pressure (SBP and DBP)
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List additional health endpoints (separately). 2 Pulse rate
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List additional health endpoints (separately).3
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List additional health endpoints (separately).4
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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 Medline Automatic Blood Pressure Monitor
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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.) Each participant received the same treatment and served as their own controls
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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) None
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What conflicts of interest were reported? No competing financial interests exist.
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Refid 10314
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What were the sources of funding? This research was supported by National Institutes of Health (NIH) grants AA019795 and GM103436 awarded to CA Marczinski. The funding sources had no other involvement in this research other than financial support. The content is solely the responsibility of the authors and does not necessarily represent the official view of National Institute of Alcohol Abuse and Alcoholism, the National Institute of General Medical Sciences, or the National Institutes of Health.
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Results & Comparisons

No Results found.