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

Not Applicable

Completed

• Conditions: Choroid
• Interventions: Dietary Supplement: RedBull® energy drink

• Registration Number: NCT02856256
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-12
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Status Verified: 2017-05
• Primary Completion: 2017-05-29
• Study Completion: 2017-05-29
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RedBull® energy drink	RedBull® energy drink	-

Primary Outcome Measures

Name	Time	Method
Intra-patient variation of the choroidal thickness	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®.

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France