Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

ProMedica Health System48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

Conditions

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

Regular "5-hour Energy"OTHER

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

Decaf "5-hour Energy"OTHER

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

Compounded concentrated caffeine liquidOTHER

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 waterOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At one, three, and five hours after taking the study product

Secondary Outcomes

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.

Time frame: Within five hours after taking study product