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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.
Please see brief summary contained above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ingredient | Active Comparator | Regular "5-hour Energy" |
|
| Active ingredient-2 | Active Comparator | "5-hour Energy Decaf" |
|
| Active ingredient-3 | Active Comparator | Compounded caffeine product 135 mg/2 ounces |
|
| Placebo | Placebo Comparator | Flavored placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular "5-hour Energy" | Other | Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Study product consumed | There is a space on each assessment tool for patients to guess what study product they think that they consumed on that date. | Within the five hours after taking the study product |
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flower Hospital Family Medicine Residency | Sylvania | Ohio | 43560 | United States |
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| Label | URL |
|---|---|
| Energy Shots Review | View source |
| 5-hour Energy Website | View source |
| Source for caffeine content of many commercially available products |
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| Decaf "5-hour Energy" | Other | Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.) |
|
|
| Compounded concentrated caffeine liquid | Other | 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" |
|
| Flavored bottled water | Other | Bottled water will be flavored and colored to serve as a placebo product for this trial. |
|
|
| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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