Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

Study Overview
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Brief Summary
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The line of 5-hour Energy® products are available over-the-counter as energy supplements. The appeal of these products involves ease of use, low caloric value, and the absence of sugar to prevent a crash later in the day. The definitive efficacy and potency of the products is unknown due to the lack of evidence-based clinical reports. It is suspected that the efficacy related to these products is due to the caffeine content, which was reported as 138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this randomized, double-blind, placebo controlled, four way crossover study is to evaluate the efficacy of 5-hour Energy®, 5-Hour Energy Decaf®, caffeine, and placebo for perceived energy and wakefulness.

Detailed Description
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Please see brief summary contained above.

Official Title
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Efficacy of 5-hour Energy®, 5-Hour Energy Decaf®, and Caffeine for Perceived Energy and Wakefulness

Conditions
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Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness

Intervention / Treatment
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* Other: Regular 5-hour Energy
* Other: Decaf 5-hour Energy
* Other: Compounded concentrated caffeine liquid
* Other: Flavored bottled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be age 18 years or older who consume no more than five caffeinated beverages and products per day. One caffeinated beverage is defined as any of the following: six ounces of cold or hot coffee or tea, twelve ounces of soda with caffeine, or one energy drink. Exclusion Criteria: Age less than 18 years Subjects who are pregnant or breast-feeding Diagnosis of any of the following disease states: Attention Deficit Hyperactive Disorder Anxiety Coronary Artery Disease Cardiac arrhythmias Cerebral vascular accident Narcolepsy Seizure disorders Uncontrolled hypertension Active therapy with stimulant medications - any medications containing amphetamine, atomoxetine, dextroamphetamine, diethylpropion, lisdexamfetamine, methylphenidate, phentermine, or modafinil Use of decongestants or other products containing phenylephrine or pseudoephedrine for more than 15 days within the past 30 days Subjects who work third shift or rotate to two or more different shifts for their job, not allowing them to have a regular sleep schedule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active ingredient<br>Regular 5-hour Energy | Other: Regular 5-hour Energy<br>* Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)<br>* Other names: Original brand 5-Hour Energy product;|
| Active Comparator: Active ingredient-2<br>5-hour Energy Decaf | Other: Decaf 5-hour Energy<br>* Commercially available 5-Hour Energy Decaf product in the amount that is packaged (1.93 fl. oz.)<br>* Other names: 5-hour Energy Decaf;|
| Active Comparator: Active ingredient-3<br>Compounded caffeine product 135 mg/2 ounces | Other: Compounded concentrated caffeine liquid<br>* Concentrated caffeine liquid has been used to compound a 135 mg/2 ounce caffeine product, which contains the same amount of caffeine as a regular 5-hour Energy<br>|
| Placebo Comparator: Placebo<br>Flavored placebo | Other: Flavored bottled water<br>* Bottled water will be flavored and colored to serve as a placebo product for this trial.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective wakefulness levels based on assessment tool rankings | Subjects are provided with assessment tools to use for each product. The tool contains the Stanford Sleepiness Scale to assess for wakefulness levels. All appropriate options are listed, and subjects are required to circle one option at one, three, and five hours after taking the study product for the day. | At one, three, and five hours after taking the study product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing adverse effects associated with study products | Each assessment tool has a space for subjects to list any side effects that were experienced throughout the five hour period of time after taking a study product. | Within five hours after taking study product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy drinks, Wakefulness, Caffeine