Clinical trial NCT01755299: Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels
Official title: Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness
Keywords: Energy drinks
Wakefulness
Caffeine
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective wakefulness levels based on assessment tool rankings
timeFrame: At one, three, and five hours after taking the study product
Secondary outcomes:
measure: Number of patients experiencing adverse effects associated with study products
timeFrame: Within five hours after taking study product
Other outcomes:
measure: Study product consumed
timeFrame: Within the five hours after taking the study product
Locations:
city: Sylvania
country: United States
facility: Flower Hospital Family Medicine Residency
state: Ohio
Study officials:
References: