Recruiting
Early Phase 1

Observational Study

Sponsor:

Université de Montréal

Code:

NCT01827150

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Redbull, energy drink

Study Details

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.

Conditions

Healthy

Study ID

NCT01827150

Start date

Jun, 2013

Status verified date

Apr, 2013

Completion date

Apr, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

Interventions

Redbull, energy drink

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

Primary outcome measure

  • Pupillary dilation [ Time Frame: T=-30 minutes ]
  • Baseline measurement before the ingestion of either Redbull or an equal amount of water [ Time Frame: T=-10 minutes ]
  • Ingestion of Redbull/Water [ Time Frame: T=0 minutes ]
  • Measurement of major variables [ Time Frame: T= 15, 30, 45, 60 minutes ]
  • Measurement of minor variables [ Time Frame: T=30, 60 minutes ]

Central Contacts and Locations

Central contacts

Vasile Diaconu, PhD

514-343-6111vasile.diaconu@umontreal.ca

Locations

École d'optométrie de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H3T 1P1

Contacts

Liliane Le-Ngoc

5148230615liliane.linh.lan.le-ngoc@umontreal.ca

Thuy-Anh Duong

5145707018thuy-anh.duong@umontreal.ca

More Information

Sponsor

Université de Montréal

Last update posted

Jul 23, 2013

Last verified

Apr, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2013-07-23.