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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 behavior*?
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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

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There are currently no secondary publications defined for this study.


Extraction Form: Behavior - Design Details - INCLUDED Studies
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 10314
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What outcome is being evaluated in this paper? Behavior
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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. Profile of Mood States (POMS) brief form.16,17. This 30- adjective rating scale is used to assess current mood. Each adjective is rated on a 5-point scale that ranges from 0 = ‘‘not at all’’ to 4 = ‘‘extremely.’’ Six mood scales are summed separately, which include Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion- Bewilderment. This scale is known to be sensitive to the acute administration of caffeine. 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 [POMS} 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.
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How many outcome-specific endpoints are evaluated? 5
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Depression-Dejection
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List additional health endpoints (separately). Fatigue-Inertia
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List additional health endpoints (separately)
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Notes POMS also measured Vigor-Activity
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Clinical
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Physiological
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Other
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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? Subjective
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Optional: Name of Method or short description Profile of Mood States (POMS) brief form.16,17. This 30- adjective rating scale is used to assess current mood. Each adjective is rated on a 5-point scale that ranges from 0 = ‘‘not at all’’ to 4 = ‘‘extremely.’’ Six mood scales are summed separately, which include Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. This scale is known to be sensitive to the acute administration of caffeine.
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Caffeine (general)
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Coffee
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Chocolate
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Energy drinks Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured Measured
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Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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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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Provide a general description of results (as reported by the authors). Subjective POMS ratings The mean POMS ratings for the six mood scales were not significantly different at baseline ( p > 0.24). Mean (standard deviation [SD]) POMS ratings following dose administration are presented in Table 2. Results of the ANOVA for the POMS Fatigue-Inertia ratingsrevealed a significant main effect of Dose, F(2, 26) = 4.56, p = 0.020, and a significant main effect of Time, F(5, 65) = 3.35, p = 0.009. There was no significant interaction in this analysis ( p = 0.79). Post-hoc LSD tests for the main effect of Dose revealed that Fatigue-Inertia ratings were significantly lower following consumption of the energy shot when compared to both the placebo and no drink conditions ( p < 0.027). The Fatigue-Inertia ratings did not differ for the placebo and no drink conditions ( p = 0.415). The post-hoc LSD tests for the main effect of Time revealed that Fatigue-Inertia ratings increased with time, as ratings were significantly higher at 220, 280, and 340 minutes when compared to the first 40 minute measurement ( p < 0.05). Results of the ANOVA for the POMS Confusion-Bewilderment ratings revealed a significant main effect of Dose, F(2, 26) = 5.55, p = 0.010, and a significant main effect of Time, F(5, 65) = 4.17, p = 0.002. There was no significant interaction in this analysis ( p = 0.33). Post-hoc LSD tests for themain effect of Dose revealed that Confusion-Bewilderment ratings were significantly higher following consumption of the energy shot when compared to the no drink condition ( p = 0.007). There were no significant differences for the energy shot versus placebo condition ( p = 0.095) and the placebo versus no drink condition ( p = 0.125). The post-hoc LSD tests for the main effect of Time revealed that Confusion-Bewilderment ratings decreased with time, as ratings were significantly lower at the 280 and 340 minute time points when compared to the first 40 minute measurement ( p < 0.024). Results of the ANOVA for the Tension-Anxiety ratings on the POMS revealed a significant Dose · Time interaction, F(10, 130) = 1.95, p = 0.044. To understand the interaction further, separate repeated measures ANOVAs were conducted to examine the effect of Dose separately at each time point. There was a significant effect of Dose when examined at the first 40 minute time point, F(2, 26) = 4.87, p = 0.016. Posthoc LSD tests for 40 minutes revealed that Tension-Anxiety ratings were significantly higher after the energy shot when compared to the no drink condition ( p = 0.028). There was also a nonsignificant trend for Tension-Anxiety ratings to be higher after the energy shot when compared to the placebo condition ( p = 0.057). The no drink and placebo conditions did not differ ( p = 0.336). For the ANOVAs conducted to examine the effect of Dose at the other time points, there were no other significant effects ( p > 0.38). Finally, the results of the ANOVA for the POMS Depression- Dejection ratings revealed no significant main effects or interaction ( p > 0.05). Similarly, the results of the ANOVA for the POMS Anger-Hostility ratings revealed no significant main effects or interaction ( p > 0.13).
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? The findings revealed that consumption of the energy shot did improve subjective state, as anticipated. Administration of the energy shot resulted in increased ratings of Vigor- Activity and decreased ratings of Fatigue-Inertia. The POMS ratings also revealed that the energy shot resulted in modest increased ratings of Tension-Anxiety early in testing.While subjective state was altered by the energy shot, it did not improve objective performance as measured by the cued go/no-go behavioral control task.
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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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What conflicts of interest were reported? No competing financial interests exist.
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Does the exposure (dose) need to be standardized to the SR? Yes
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest). Authors refer to website which defines a 2 oz shot of 5-hour Energy as containing 200 mg caffeine.
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Tension-Anxiety - LOAEL = 200 mg (higher at 40 min post dose) Depression-Dejection = NOAEL = 200 mg Anger-Hostility = NOAEL = 200 mg Confusion-Bewilderment - LOAEL = 200 mg (higher at 40 min post dose) Fatigue-Inertia - NOAEL = 200 mg
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. single dose Confusion-Bewilderment was only significant when compared to the no-drink condition, not when compared to placebo
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What is the importance of the study with respect to the adverseness of the outcome? Important
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