Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

NCT01755299 | Completed DMC

• 1 other identifier: 5HE-TOL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Number of patients experiencing adverse effects associated with study products

  Within five hours after taking study product

Other Outcomes (1)

• Study product consumed

  Within the five hours after taking the study product

Study Arms (4)

Active ingredient

ACTIVE COMPARATOR

Regular "5-hour Energy"

Other: Regular "5-hour Energy"

Active ingredient-2

ACTIVE COMPARATOR

"5-hour Energy Decaf"

Other: Decaf "5-hour Energy"

Active ingredient-3

ACTIVE COMPARATOR

Compounded caffeine product 135 mg/2 ounces

Other: Compounded concentrated caffeine liquid

Placebo

PLACEBO COMPARATOR

Flavored placebo

Other: Flavored bottled water

Interventions

Regular "5-hour Energy" OTHER

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

Also known as: Original brand "5-Hour Energy" product

Active ingredient

Decaf "5-hour Energy" OTHER

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

Also known as: "5-hour Energy Decaf"

Active ingredient-2

Compounded concentrated caffeine liquid 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"

Active ingredient-3

Flavored bottled water OTHER

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

Also known as: Water, Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

Flower Hospital Family Medicine Residency

Sylvania, Ohio, 43560, United States

Location

Related Links

• Energy Shots Review
• 5-hour Energy Website
• Source for caffeine content of many commercially available products

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Resident

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

US (1)