Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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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Detailed Description

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Please see brief summary contained above.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active ingredient

Regular "5-hour Energy"

Group Type ACTIVE_COMPARATOR

Regular "5-hour Energy"

Intervention Type OTHER

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

Active ingredient-2

"5-hour Energy Decaf"

Group Type ACTIVE_COMPARATOR

Decaf "5-hour Energy"

Intervention Type OTHER

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

Active ingredient-3

Compounded caffeine product 135 mg/2 ounces

Group Type ACTIVE_COMPARATOR

Compounded concentrated caffeine liquid

Intervention Type 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"

Placebo

Flavored placebo

Group Type PLACEBO_COMPARATOR

Flavored bottled water

Intervention Type OTHER

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

Interventions

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Regular "5-hour Energy"

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

Intervention Type OTHER

Decaf "5-hour Energy"

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

Intervention Type 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"

Intervention Type OTHER

Flavored bottled water

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

Intervention Type OTHER

Other Intervention Names

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Original brand "5-Hour Energy" product "5-hour Energy Decaf" Water Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes