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Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755299
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
Michelle Piel, 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.

Condition or disease Intervention/treatment Phase
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" Other: Decaf "5-hour Energy" Other: Compounded concentrated caffeine liquid Other: Flavored bottled water Not Applicable

Detailed Description:
Please see brief summary contained above.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Active ingredient
Regular "5-hour Energy"
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

Active Comparator: Active ingredient-2
"5-hour Energy Decaf"
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"

Active Comparator: Active ingredient-3
Compounded caffeine product 135 mg/2 ounces
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"

Placebo Comparator: Placebo
Flavored placebo
Other: Flavored bottled water
Bottled water will be flavored and colored to serve as a placebo product for this trial.
Other Names:
  • Water
  • Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01755299

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United States, Ohio
Flower Hospital Family Medicine Residency
Sylvania, Ohio, United States, 43560
Sponsors and Collaborators
ProMedica Health System
Additional Information:
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Responsible Party: Michelle Piel, Pharmacy Resident, ProMedica Health System Identifier: NCT01755299    
Other Study ID Numbers: 5HE-TOL
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Michelle Piel, ProMedica Health System:
Energy drinks
Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents