Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Piel, ProMedica Health System
ClinicalTrials.gov Identifier:
NCT01755299
First received: December 18, 2012
Last updated: July 6, 2013
Last verified: July 2013

December 18, 2012
July 6, 2013
December 2012
April 2013   (final data collection date for primary outcome measure)
Subjective wakefulness levels based on assessment tool rankings [ Time Frame: At one, three, and five hours after taking the study product ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01755299 on ClinicalTrials.gov Archive Site
Number of patients experiencing adverse effects associated with study products [ Time Frame: Within five hours after taking study product ] [ Designated as safety issue: Yes ]
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.
Same as current
Study product consumed [ Time Frame: Within the five hours after taking the study product ] [ Designated as safety issue: No ]
There is a space on each assessment tool for patients to guess what study product they think that they consumed on that date.
Same as current
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
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"
    Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
    Other Name: Original brand "5-Hour Energy" product
  • 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"
  • 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.
    Other Names:
    • Water
    • Placebo
  • Active Comparator: Active ingredient
    Regular "5-hour Energy"
    Intervention: Other: Regular "5-hour Energy"
  • Active Comparator: Active ingredient-2
    "5-hour Energy Decaf"
    Intervention: Other: Decaf "5-hour Energy"
  • Active Comparator: Active ingredient-3
    Compounded caffeine product 135 mg/2 ounces
    Intervention: Other: Compounded concentrated caffeine liquid
  • Placebo Comparator: Placebo
    Flavored placebo
    Intervention: Other: Flavored bottled water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01755299
5HE-TOL
Yes
Michelle Piel, ProMedica Health System
ProMedica Health System
Not Provided
Not Provided
ProMedica Health System
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP