Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Piel, ProMedica Health System
ClinicalTrials.gov Identifier:
NCT01755299
First received: December 18, 2012
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness
Other: Regular "5-hour Energy"
Other: Decaf "5-hour Energy"
Other: Compounded concentrated caffeine liquid
Other: Flavored bottled water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness

Resource links provided by NLM:


Further study details as provided by ProMedica Health System:

Primary Outcome Measures:
  • Subjective wakefulness levels based on assessment tool rankings [ Time Frame: At one, three, and five hours after taking the study product ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of patients experiencing adverse effects associated with study products [ Time Frame: Within five hours after taking study product ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Study product consumed [ Time Frame: Within the five hours after taking the study product ] [ Designated as safety issue: No ]
    There is a space on each assessment tool for patients to guess what study product they think that they consumed on that date.


Enrollment: 48
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active ingredient
Regular "5-hour Energy"
Other: Regular "5-hour Energy"
Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
Other Name: Original brand "5-Hour Energy" product
Active Comparator: Active ingredient-2
"5-hour Energy Decaf"
Other: Decaf "5-hour Energy"
Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.)
Other Name: "5-hour Energy Decaf"
Active Comparator: Active ingredient-3
Compounded caffeine product 135 mg/2 ounces
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"
Placebo Comparator: Placebo
Flavored placebo
Other: Flavored bottled water
Bottled water will be flavored and colored to serve as a placebo product for this trial.
Other Names:
  • Water
  • Placebo

Detailed Description:

Please see brief summary contained above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755299

Locations
United States, Ohio
Flower Hospital Family Medicine Residency
Sylvania, Ohio, United States, 43560
Sponsors and Collaborators
ProMedica Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Michelle Piel, Pharmacy Resident, ProMedica Health System
ClinicalTrials.gov Identifier: NCT01755299     History of Changes
Other Study ID Numbers: 5HE-TOL
Study First Received: December 18, 2012
Last Updated: July 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ProMedica Health System:
Energy drinks
Wakefulness
Caffeine

Additional relevant MeSH terms:
Caffeine
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014