Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and WakefulnessNCT01755299
Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels
A study testing Regular "5-hour Energy", Decaf "5-hour Energy" and Compounded concentrated caffeine liquid in people with Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness, run by ProMedica Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness
- What is being tested?
- Regular "5-hour Energy", Decaf "5-hour Energy" and Compounded concentrated caffeine liquid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Flower Hospital Family Medicine Residency
Sylvania, Ohio, 43560
About this study
Official title: Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness
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.
Read the detailed description
Please see brief summary contained above.
- Being tested
- Regular "5-hour Energy", Decaf "5-hour Energy", Compounded concentrated caffeine liquid, Flavored bottled water
- Keywords
- Energy drinks, Wakefulness, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular "5-hour Energy"Other
Also called Original brand "5-Hour Energy" product
Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
Decaf "5-hour Energy"Other
Also called "5-hour Energy Decaf"
Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.)
Compounded concentrated caffeine liquidOther
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"
Flavored bottled waterOther
Also called Water, Placebo
Bottled water will be flavored and colored to serve as a placebo product for this trial.
| Study group | Role | What they receive |
|---|---|---|
| Active ingredient | Active comparator | Regular "5-hour Energy" Receives: Other: Regular "5-hour Energy" |
| Active ingredient-2 | Active comparator | "5-hour Energy Decaf" Receives: Other: Decaf "5-hour Energy" |
| Active ingredient-3 | Active comparator | Compounded caffeine product 135 mg/2 ounces Receives: Other: Compounded concentrated caffeine liquid |
| Placebo | Placebo comparator | Flavored placebo Receives: Other: Flavored bottled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one, three, and five hours after taking the study product
Secondary outcomes (1)
Number of patients experiencing adverse effects associated with study products
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.
Measured: Within five hours after taking study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and WakefulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Piel, ProMedica Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755299
- Sponsor's protocol ID
- 5HE-TOL
- Status last verified
- Jul 2013
- First submitted
- 18 Dec 2012
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness
- ClinicalTrials.gov ID
- NCT01755299
- Acronym / sponsor ID
- 5HE-TOL
- Keywords
- Energy drinks, Wakefulness, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active ingredient | Active comparator | Other: Regular "5-hour Energy"Regular "5-hour Energy" |
| Active ingredient-2 | Active comparator | Other: Decaf "5-hour Energy""5-hour Energy Decaf" |
| Active ingredient-3 | Active comparator | Other: Compounded concentrated caffeine liquidCompounded caffeine product 135 mg/2 ounces |
| Placebo | Placebo comparator | Other: Flavored bottled waterFlavored placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Age less than 18 years
- Subjects who are pregnant or breast-feeding
- Diagnosis of any of the following disease states:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular "5-hour Energy"Also: Original brand "5-Hour Energy" productAmount equivalent to the package commercially packaged and sold (1.93 fl. oz.) | Other | Active ingredient |
| Decaf "5-hour Energy"Also: "5-hour Energy Decaf"Commercially available "5-Hour Energy Decaf" product in the amount that is packaged (1.93 fl. oz.) | Other | Active ingredient-2 |
| Compounded concentrated caffeine liquidConcentrated 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" | Other | Active ingredient-3 |
| Flavored bottled waterAlso: Water, PlaceboBottled water will be flavored and colored to serve as a placebo product for this trial. | Other | Placebo |
Primary outcome
Subjective wakefulness levels based on assessment tool rankings
Time frame: 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.
1 secondary outcome
Number of patients experiencing adverse effects associated with study products
Time frame: Within five hours after taking study product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Energy Shots ReviewLink provided by the sponsor.
- 5-hour Energy WebsiteLink provided by the sponsor.
- Source for caffeine content of many commercially available productsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular "5-hour Energy", Decaf "5-hour Energy" and Compounded concentrated caffeine liquid in people with Focus: to Compare a Commercially Available Energy Drink, B Vitamins, Caffeine Alone, and Placebo for Effectiveness on Perceived Energy Level and Wakefulness, run by ProMedica Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective wakefulness levels based on assessment tool rankings (time frame: At one, three, and five hours after taking the study product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.