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
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:
- The effect after the intake of a can of Redbull (250 ml)
- 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:
- 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.
- The IOP measured with iCare tonometer decreases after the consumption of the energy drink Redbull compared to an equal volume of water.
- The systemic blood pressure, measured with an automatic sphygmomanometer remains constant after ingestion of Redbull energy drink or an equal volume of water.
- Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull energy drink compared to an equal volume of water.
- 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|
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 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|
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
- 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.
- 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.
- Ingestion of Redbull/Water [ Time Frame: T=0 minutes ]Ingestion of 250 ml of the energy drink Redbull or an equal amount of water
- 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.
- 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.
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
|Contact: Vasile Diaconu, PhD||514-343-6111 ext email@example.com|
|École d'optométrie de l'Université de Montréal||Recruiting|
|Montréal, Quebec, Canada, H3T 1P1|
|Contact: Liliane Le-Ngoc 5148230615 firstname.lastname@example.org|
|Contact: Thuy-Anh Duong 5145707018 email@example.com|
|Study Director:||Vasile Diaconu, PhD||Université de Montréal|
|Principal Investigator:||Thuy-Anh Duong||Université de Montréal|
|Principal Investigator:||Liliane Le-Ngoc||Université de Montréal|