Study of the Choroidal Thickness Variations After Ingestion of RedBull® Energy Drink (REDCHO)

May 29, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's blood. The choroidal thickness fluctuates according to the state of fullness of its constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium) are intimately linked and are subject to modifications during the ingestion of caffeine and taurine combined. Several authors have shown a significant decrease of the choroidal thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in the retina. Recent studies have shown the importance of this amino acid in the physiology of both, retinal pigmentary epithelium and retinal ganglion cells.

RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the equivalent of a coffee mug) and 1 g of taurine.

This pilot trial aims to study the variations of the choroidal thickness and to describe possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and taurine. The results of this study will act as a reference for an ulterior trial aiming specific choroidal pathologies of young patients, such as the central serous chorioretinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18-45 years old
  • subject under no medical treatment who can alter choroidal depth (sildenafil, diuretics, steroids, etc)
  • Non smoker
  • subject who has not ingested any caffeine within the 12 hours prior to the trial's inclusion
  • subject well informed of the trial and having signed consent

Exclusion Criteria:

  • subject with retinal and/or choroidal abnormalities
  • Diabetic subject
  • Hypermetropia > +3 diopters and myopia < -3 diopters
  • History of intra-ocular surgery or laser
  • subject with a history of retinal pathologies
  • Subject not affiliated to French social security
  • Subject under juridical protection
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RedBull® energy drink
Dietary supplement: RedBull® energy drink
Subjects consume 25 mL of RedBull® energy drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-patient variation of the choroidal thickness
Time Frame: up to 4 hours
Measure of choroidal thickness by Optical Coherence Tomography (OCT), 5 minutes before ingesting 25cl RedBull® then 5 minutes, 30 minutes, 1 hour, 2 hours and 4 hours after ingestion of RedBull®.
up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2015

Primary Completion (Actual)

May 29, 2017

Study Completion (Actual)

May 29, 2017

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 29, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMT_2015_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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