Study of the Choroidal Thickness Variations After Ingesti... | NCT02856256

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

NCT02856256

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Choroid

Interventions

RedBull® energy drink

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2015Actual

Primary Completion Date

May 29, 2017Actual

Completion Date

May 29, 2017Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2017

Last Update Posted Date

May 31, 2017Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RedBull® energy drink	Experimental		Dietary Supplement: RedBull® energy drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RedBull® energy drink	Dietary Supplement	Subjects consume 25 mL of RedBull® energy drink	RedBull® energy drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique Adolphe de Rothschild		Paris		75019	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34024522	Derived	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.