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The Influence of Energy Drinks on the Blood Oxygenation Concentration of the Optic Nerve

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ClinicalTrials.gov Identifier: NCT01827150
Recruitment Status : Unknown
Verified April 2013 by Université de Montréal.
Recruitment status was:  Recruiting
First Posted : April 9, 2013
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The present proposal investigates the influence of energy drinks on the blood oxygenation concentration of the optic nerve on healthy subjects. On a voluntary basis, 15 subjects, man or woman, will be selected to undergo this experiment. Many factors can influence the blood oxygenation concentration of the optic nerve, which will be measured also during this experiment, namely: Intra ocular pressure (IOP), blood pressure, heart rate and systemic hemoglobin saturation.

The subjects will have to be tested twice to test the two conditions of this experiment:

  1. The effect after the intake of a can of Redbull (250 ml)
  2. The difference with the intake of 250 ml of water

The purpose of this study is to determine if the blood oxygenation concentration of the optic nerve varies after having ingested 250 ml of Redbull.

Our hypothesis are:

  1. The blood oxygenation concentration of the optic nerve measured with OSOME (see detailed description below), decreases due to the consumption of the energy drink Redbull compared to an equal volume of water.
  2. The IOP measured with iCare tonometer decreases after the consumption of the energy drink Redbull compared to an equal volume of water.
  3. The systemic blood pressure, measured with an automatic sphygmomanometer remains constant after ingestion of Redbull energy drink or an equal volume of water.
  4. Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull energy drink compared to an equal volume of water.
  5. The rate of systemic hemoglobin saturation measured with a pulse oximeter remains constant after the ingestion of a Redbull energy drink or an equal volume of water.

Condition or disease Intervention/treatment Phase
Healthy Drug: Redbull, energy drink Early Phase 1

Detailed Description:

The blood oxygenation will be assessed using a machine called the OSOME. The online spectroreflectometry oxygenation measurement in the eye (OSOME) was used to measure eye fundus oxygenation, more precisely optic nerve head capillaries structures oxygenation, by full spectrum reflectometry (1020 wavelength from 400 to 700nm) in real time (O.S.O.M.E., Faubert & Diaconu US patent # 5,919,132) with 2% accuracy. It includes a fundus camera (Topcon, Osaka, Japan) coupled with a digital video camera (USB) and a detection unit composed of a multi-channel spectrograph and a charged coupled device (CCD).

In order to use this machine, upon arrival, the patient's right eye needs to be dilated with drops of proparacaine hydrochloride 0.5%, tropicamide 1% and phenylephrine hydrochloride 2.5%. The patient is required to rest for 20 minutes to allow a complete dilatation of the pupil before using the OSOME.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Energy Drinks on the Blood Oxygenation Concentration of the Optic Nerve
Study Start Date : June 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Redbull, optic nerve

15 subjects will each be drinking a can of Redbull (250 ml) and an equal amount of water (250 ml) in two different sessions. The order in which they will do so, is determined by randomization.

Intervention: Drug: Redbull, energy drink

Drug: Redbull, energy drink
A can of 250 mL of the energy drink Redbull will be administered randomly to the subjects


Outcome Measures

Primary Outcome Measures :
  1. Pupillary dilation [ Time Frame: T=-30 minutes ]
    Upon arrival, the patient's right eye needs to be dilated with one drop of proparacaine hydrochloride 0.5%, one drop of tropicamide 1% and one drop of phenylephrine hydrochloride 2.5%. The patient is required to rest for 20 minutes to allow a complete dilatation of the pupil.

  2. Baseline measurement before the ingestion of either Redbull or an equal amount of water [ Time Frame: T=-10 minutes ]
    Baseline measurement of the blood oxygenation concentration of the optic nerve, the IOP, the heart rate, the blood pressure and the rate of systemic hemoglobin saturation.

  3. Ingestion of Redbull/Water [ Time Frame: T=0 minutes ]
    Ingestion of 250 ml of the energy drink Redbull or an equal amount of water

  4. Measurement of major variables [ Time Frame: T= 15, 30, 45, 60 minutes ]
    After having ingested 250 ml of Redbull or an equal volume of water, the blood oxygenation concentration of the optic nerve, the IOP and the heart rate will be measured every 15 minutes for a total of 60 minutes.

  5. Measurement of minor variables [ Time Frame: T=30, 60 minutes ]
    The blood pressure and rate of systemic hemoglobin saturation will be measured every 30 minutes for a total of 60 minutes after the ingestion of 250 ml of the energy drink Redbull or an equal amount of water.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be a man or a woman in good general health
  • Be a non-smoker
  • Weigh between 45 kg and 80 kg
  • Have an intra ocular pressure inferior to 22 mm Hg
  • Have a blood pressure inferior to 120/80 mm Hg
  • Absence of systemic diseases (including hypertension, diabetes, or vascular disease),
  • Absence of any ocular disease
  • Evidence of abstinence from caffeine or caffeine beverages 48 hours prior to the experiment
  • Abstinence from use of any systemic drugs and/or alcohol

Exclusion Criteria:

  • Any subject who has family or personal history of glaucoma will be excluded
  • All the subjects who didn't respect the inclusion criteria

There is no monetary compensation for participating in this study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827150


Contacts
Contact: Vasile Diaconu, PhD 514-343-6111 ext 5031 vasile.diaconu@umontreal.ca

Locations
Canada, Quebec
École d'optométrie de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H3T 1P1
Contact: Liliane Le-Ngoc    5148230615    liliane.linh.lan.le-ngoc@umontreal.ca   
Contact: Thuy-Anh Duong    5145707018    thuy-anh.duong@umontreal.ca   
Sponsors and Collaborators
Université de Montréal
Investigators
Study Director: Vasile Diaconu, PhD Université de Montréal
Principal Investigator: Thuy-Anh Duong Université de Montréal
Principal Investigator: Liliane Le-Ngoc Université de Montréal
More Information

Responsible Party: Université de Montréal
ClinicalTrials.gov Identifier: NCT01827150     History of Changes
Other Study ID Numbers: 13-030-CERES-D
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: April 2013