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

NCT01827150 | Unknown Early Phase 1 DMC

• 1 other identifier: 13-030-CERES-D
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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. 1.The effect after the intake of a can of Redbull (250 ml)
2. 2.The difference with the intake of 250 ml of water
3. 3.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.
4. 4.The IOP measured with iCare tonometer decreases after the consumption of the energy drink Redbull compared to an equal volume of water.
5. 5.The systemic blood pressure, measured with an automatic sphygmomanometer remains constant after ingestion of Redbull energy drink or an equal volume of water.
6. 6.Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull energy drink compared to an equal volume of water.
7. 7.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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

Drug: Redbull, energy drink

Interventions

Redbull, energy drink DRUG

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

Redbull, optic nerve

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any subject who has family or personal history of glaucoma will be excluded
• There is no monetary compensation for participating in this study.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

École d'optométrie de l'Université de Montréal

Montreal, Quebec, H3T 1P1, Canada

RECRUITING

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vasile Diaconu, PhD

  Université de Montréal

  STUDY DIRECTOR

• Thuy-Anh Duong

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Liliane Le-Ngoc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasile Diaconu, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 23, 2013

Record last verified: 2013-04

Locations

CA (1)