NCT01755299

Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: ProMedica Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Please see brief summary contained above.

Conditions

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

Interventions

Type	Name	Description
OTHER	Regular "5-hour Energy"	Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
OTHER	Decaf "5-hour Energy"	Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.)
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"
OTHER	Flavored bottled water	Bottled water will be flavored and colored to serve as a placebo product for this trial.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-24
• Last updated: 2013-07-09

Locations

1 site across 1 country: United States