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OpenTrials
Completed

NCT Number: NCT01755299

Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flower Hospital Family Medicine Residency

Sylvania, Ohio, 43560, United States

About this study

Please see brief summary contained above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular "5-hour Energy"

Other

Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)

Other names: Original brand "5-Hour Energy" product

Decaf "5-hour Energy"

Other

Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.)

Other names: "5-hour Energy Decaf"

Compounded concentrated caffeine liquid

Other

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"

Flavored bottled water

Other

Bottled water will be flavored and colored to serve as a placebo product for this trial.

Other names: Water, Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2012
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.