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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Redbull, energy drink

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Vasile Diaconu, PhD; Phone Number: 5031 514-343-6111; Email: vasile.diaconu@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1P1
      • Recruiting
      • École d'optométrie de l'Université de Montréal
      • Contact: Liliane Le-Ngoc; Phone Number: 5148230615; Email: liliane.linh.lan.le-ngoc@umontreal.ca
      • Contact: Thuy-Anh Duong; Phone Number: 5145707018; Email: thuy-anh.duong@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary dilation	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.	T=-30 minutes
Baseline measurement before the ingestion of either Redbull or an equal amount of water	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.	T=-10 minutes
Ingestion of Redbull/Water	Ingestion of 250 ml of the energy drink Redbull or an equal amount of water	T=0 minutes
Measurement of major variables	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.	T= 15, 30, 45, 60 minutes
Measurement of minor variables	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.	T=30, 60 minutes

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 13-030-CERES-D