Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

Not Applicable

Completed

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

• Registration Number: NCT01755299
• Lead Sponsor: ProMedica Health System

Brief 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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-06
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Subjective wakefulness levels based on assessment tool rankings	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients experiencing adverse effects associated with study products	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.

Trial Locations

Locations (1)

Flower Hospital Family Medicine Residency; 🇺🇸 Sylvania, Ohio, United States