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

Choroid Clinical Trial

— REDCHO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856256
• Other study ID #: MMT_2015_2
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: May 29, 2017
• Start date: November 12, 2015
• Est. completion date: May 29, 2017

Study information

• Verified date: May 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 29, 2017
• Est. primary completion date: May 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Choroid

Intervention

Dietary Supplement:
• RedBull® energy drink
Subjects consume 25 mL of RedBull® energy drink

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-patient variation of the choroidal thickness	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