Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness
Conditions
Keywords
Energy drinks, Wakefulness, Caffeine
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.
Detailed description
Please see brief summary contained above.
Interventions
OTHERRegular 5-hour Energy
Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
OTHERDecaf 5-hour Energy
Commercially available 5-Hour Energy Decaf product in the amount that is packaged (1.93 fl. oz.)
OTHERCompounded 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
OTHERFlavored bottled water
Bottled water will be flavored and colored to serve as a placebo product for this trial.
Sponsors
ProMedica Health System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective wakefulness levels based on assessment tool rankings | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients experiencing adverse effects associated with study products | 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
| Measure | Time frame | Description |
|---|---|---|
| Study product consumed | 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. |
Countries
United States
Outcome results
None listed