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NCT01755299 · ClinicalTrials.gov registry record · NA

Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

A NA study, sponsored by ProMedica Health System.

Completed
Registry status
NA
Development phase
48
Enrollment target

NCT01755299: Completed NA study, sponsored by ProMedica Health System.

NCT01755299 is a NA study that has completed, run by ProMedica Health System. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01755299, a NA study, has completed, sponsored by ProMedica Health System.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Regular "5-hour Energy"
  • OTHER Decaf "5-hour Energy"
  • OTHER Compounded concentrated caffeine liquid
  • OTHER Flavored bottled water

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2012-12
Est. Completion 2013-04
Phase NA
ProMedica Health System

12 total trials

What the finished NCT01755299 record still lists

NCT01755299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 4 interventions - of which Regular "5-hour Energy" is the first listed.

NCT01755299 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01755299 about?

NCT01755299 is a clinical study titled "Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels". 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 ...

What is the current status of trial NCT01755299?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2012-12. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01755299?

The interventions under investigation include: Regular "5-hour Energy" (OTHER), Decaf "5-hour Energy" (OTHER), Compounded concentrated caffeine liquid (OTHER), Flavored bottled water (OTHER).

Who is sponsoring clinical trial NCT01755299?

This trial is sponsored by ProMedica Health System, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01755299's enrollment target sits among peer trials

48 1381st of 2000 higher than 601 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01755299, the US trial registry maintained by the National Library of Medicine. NCT01755299 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.