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.

Study Overview

• Status: Completed
• Conditions: Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness
• Intervention / Treatment: Other: Regular "5-hour Energy"; Other: Decaf "5-hour Energy"; Other: Compounded concentrated caffeine liquid; Other: Flavored bottled water

Detailed Description

Please see brief summary contained above.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • Flower Hospital Family Medicine Residency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: "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: Placebo; Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective wakefulness levels based on assessment tool rankings	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.	At one, three, and five hours after taking the study product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients experiencing adverse effects associated with study products	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.	Within five hours after taking study product

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study product consumed	There is a space on each assessment tool for patients to guess what study product they think that they consumed on that date.	Within the five hours after taking the study product

Collaborators and Investigators

• Sponsor: ProMedica Health System

Publications and helpful links

Helpful Links

• Energy Shots Review
• 5-hour Energy Website
• Source for caffeine content of many commercially available products

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (ESTIMATE): December 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 6, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Caffeine; Wakefulness; Energy drinks
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 5HE-TOL