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UnknownNCT01827150

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

Status
Unknown
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Université de Montréal · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGRedbull, energy drinkA can of 250 mL of the energy drink Redbull will be administered randomly to the subjects

Timeline

Start date
2013-06-01
Primary completion
2013-12-01
Completion
2014-04-01
First posted
2013-04-09
Last updated
2013-07-23

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01827150. Inclusion in this directory is not an endorsement.