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临床试验/NCT02856256
NCT02856256已完成不适用

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

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Intra-patient variation of the choroidal thickness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Intra-patient variation of the choroidal thickness

时间窗: 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®.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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