HealthyEarly Phase 1NCT01827150
The Influence of Energy Drinks on the Blood Oxygenation Concentration of the Optic Nerve
A Early Phase 1 study testing Redbull, energy drink in people with Healthy, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Redbull, energy drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Apr 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
École d'optométrie de l'Université de Montréal
Montreal, Quebec, H3T 1P1
Liliane Le-Ngoc, 5148230615, liliane.linh.lan.le-ngoc@umontreal.ca
Thuy-Anh Duong, 5145707018, thuy-anh.duong@umontreal.ca
About this study
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:
Read more
- 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.
Read the 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
- Healthy
- Being tested
- Redbull, energy drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redbull, energy drinkDrug
A can of 250 mL of the energy drink Redbull will be administered randomly to the subjects
| Study group | Role | What they receive |
|---|---|---|
| Redbull, optic nerve | Experimental | 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 Receives: Drug: Redbull, energy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: T=-10 minutes
Ingestion of Redbull/Water
Ingestion of 250 ml of the energy drink Redbull or an equal amount of water
Measured: 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.
Measured: 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.
Measured: T=30, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasile Diaconu, PhD, Study director, Université de MontréalThuy-Anh Duong, Principal investigator, Université de MontréalLiliane Le-Ngoc, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827150
- Sponsor's protocol ID
- 13-030-CERES-D
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Energy Drinks on the Blood Oxygenation Concentration of the Optic Nerve
- ClinicalTrials.gov ID
- NCT01827150
- Acronym / sponsor ID
- 13-030-CERES-D
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Redbull, optic nerve | Experimental | Drug: Redbull, energy drink15 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redbull, energy drinkA can of 250 mL of the energy drink Redbull will be administered randomly to the subjects | Drug | Redbull, optic nerve |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasile Diaconu, PhD study director
Université de Montréal
Thuy-Anh Duong principal investigator
Université de Montréal
Liliane Le-Ngoc principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Redbull, energy drink in people with Healthy, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasile Diaconu, PhD (514-343-6111 ext. 5031, vasile.diaconu@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary dilation (time frame: T=-30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.