Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

ProMedica Health System

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

Treatments: Other: Regular "5-hour Energy"; Other: Decaf "5-hour Energy"; Other: Compounded concentrated caffeine liquid; Other: Flavored bottled water

Study type: Interventional

Funder types: Other

Identifiers

NCT01755299

5HE-TOL

Details and patient eligibility

About

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.

Full description

Please see brief summary contained above.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

Active ingredient

Active Comparator group

Description:

Regular "5-hour Energy"

Treatment:

Other: Regular "5-hour Energy"

Active ingredient-2

Active Comparator group

Description:

"5-hour Energy Decaf"

Treatment:

Other: Decaf "5-hour Energy"

Active ingredient-3

Active Comparator group

Description:

Compounded caffeine product 135 mg/2 ounces

Treatment:

Other: Compounded concentrated caffeine liquid

Placebo

Placebo Comparator group

Description:

Flavored placebo

Treatment:

Other: Flavored bottled water