Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

Completed · Not applicable · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01755299

Run by

ProMedica Health System

People needed

48

Starts

2012-12-01

Expected to finish

2013-04-01

Last updated by the study team

2013-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• Flower Hospital Family Medicine Residency — Sylvania, Ohio, United States

Full record on ClinicalTrials.gov

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