Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels
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|ClinicalTrials.gov Identifier: NCT01755299|
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : July 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness||Other: Regular "5-hour Energy" Other: Decaf "5-hour Energy" Other: Compounded concentrated caffeine liquid Other: Flavored bottled water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: Active ingredient
Regular "5-hour Energy"
Other: Regular "5-hour Energy"
Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
Other Name: Original brand "5-Hour Energy" product
Active Comparator: Active ingredient-2
"5-hour Energy Decaf"
Other: Decaf "5-hour Energy"
Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.)
Other Name: "5-hour Energy Decaf"
Active Comparator: Active ingredient-3
Compounded caffeine product 135 mg/2 ounces
Other: Compounded concentrated caffeine liquid
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"
Placebo Comparator: Placebo
Other: Flavored bottled water
Bottled water will be flavored and colored to serve as a placebo product for this trial.
- Subjective wakefulness levels based on assessment tool rankings [ Time Frame: At one, three, and five hours after taking the study product ]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.
- Number of patients experiencing adverse effects associated with study products [ Time Frame: Within five hours after taking study product ]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.
- Study product consumed [ Time Frame: Within the five hours after taking the study product ]There is a space on each assessment tool for patients to guess what study product they think that they consumed on that date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755299
|United States, Ohio|
|Flower Hospital Family Medicine Residency|
|Sylvania, Ohio, United States, 43560|