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

NCT02856256 | Completed

• 1 other identifier: MMT_2015_2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroid

Keywords

Energy drink; Choroid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RedBull® energy drink

EXPERIMENTAL

Dietary Supplement: RedBull® energy drink

Interventions

RedBull® energy drink DIETARY_SUPPLEMENT

Subjects consume 25 mL of RedBull® energy drink

RedBull® energy drink

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-45 years old
• subject under no medical treatment who can alter choroidal depth (sildenafil, diuretics, steroids, etc)
• Non smoker
• subject well informed of the trial and having signed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Arej N, Azar G, Salviat F, Alonso AS, Zuber K, Metten MA, Salomon L, Vasseur V, Mauget-Faysse M. Study of choroidal thickness variations after ingestion of a taurine and caffeine-containing energy drink. Clin Nutr ESPEN. 2021 Jun;43:245-249. doi: 10.1016/j.clnesp.2021.04.007. Epub 2021 Apr 17.

  PMID: 34024522 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: November 12, 2015
• Primary Completion: May 29, 2017
• Study Completion: May 29, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

FR (1)