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Completed

NCT Number: NCT02856256

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RedBull® energy drink

Dietary Supplement

Subjects consume 25 mL of RedBull® energy drink

Primary outcomes

  1. 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®.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: REDCHO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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