Study of Modification of the Density of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The primary outcome is the measure of the evolution of the macular pigment density after 10 weeks of supplementation compared with the initial measure.
研究概览
简要总结
The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized countries. The macular pigment (lutein and zeaxanthin) could play an important role in the arisen of the AMD. The food supplementation by corn with strong concentration in macular pigment could increase the density of the macular pigment. This could, in the future, represent a strategy of prevention of the AMD. The main objective of this study is to detect an increase of the macular pigment density after the consumption of this corn at healthy volunteers.
详细描述
The age macular degeneration represents the first cause of blindness in industrialized countries if it is not treated. In France, the AMD affects 600 000 persons and this figure should continue to increase, notably because of the increase of the life expectancy. The macula is responsible of the fine vision, the vision of colours and the perception of contrasts. The macular pigment is present only at the level of the macular area. This pigment is composed of three carotenoids: lutein, zeaxanthin, meso-zeaxanthin. The first two compounds are of strictly food origin and are not produced in an endogenous way. A change of the macular pigment density and/or the quality of the macular pigment is suspected to play a role in the appearance and the evolution of the AMD. The food supplementation by corn with strong concentration in macular pigment could increase the density of the macular pigment. This could, in the future, represent a strategy of prevention of the AMD. The main objective of this study is to detect an increase of the macular pigment density after the consumption of this corn at healthy volunteers. The treatment will consist in a daily consumption of a box of 125g of corn with strong zeaxanthin content during 10 weeks. This corresponds to a daily contribution of at least 1,2 mg of lutein and 2,2 mg de zeaxanthin. After the inclusion visit, the subject will be seen 5 times (after 3, 6, 8, 10, 14 weeks of treatment). In all these visits, measures of the macular pigment will be realized. A blood sample will be realized at the inclusion visit and during the visit at 6 and 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, men and women
- •Corrected visual acuity upper or equal to 8/10 in two eyes.
- •Age: 20 - 35 years
- •Free and written consent signed by the participant and the investigator before any examination required by the research
- •Subject agreeing to be registered in the national file
- •Affiliated subject of a national insurance scheme
排除标准
- •Presence of AMD signs on one or two eyes
- •Histories of other evolutionary ocular pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (glaucoma, high myopia forte (>= - 6 dioptres), strong retinopathy…)
- •Subject operated of de cataract
- •Lens Opacities (NO>=3, et/ou NC>=3, et/ou C>=1 et/ou P>=1 according to the LOCSII method)
- •Food complements in the year wich precedes (list of complements in appendix 2)
- •Hypersensitive people in the tropicamide, in the atropine, its by-products, or in one of the excipients of the tropicamide
- •Patients at risk of angle closure glaucoma
- •Body Masse Index >= 30 kg/m2
- •Current smoking or stop for less than 12 months
- •High blood pressure
- •Hyperlipidemia
- •Neuro-inflammatory diseases
- •Chronical gastro-intestinal diseases (Crohn …)
- •Taking of continuous medicine during more than one month, during the last 12 months (exception of the contraceptive pill)
- •Pregnant or breast-feeding woman
- •Vegetarian Patient
- •Participation in another clinical trial during 30 days wich precedes
- •Not compliant subjects
- •Subject without french national insurance scheme
- •Subject under guardianship judicial
研究组 & 干预措施
Healthy volunteer
干预措施: Corn zeaxanthin (Other)
结局指标
主要结局
The primary outcome is the measure of the evolution of the macular pigment density after 10 weeks of supplementation compared with the initial measure.
时间窗: 10 weeks after inclusion
次要结局
- The measure of plasmatic rate of total cholesterol, HDL-cholesterol, triglycerides, lutein and zeaxanthin, initial and in 6 and 10 weeks of supplementation(10 weeks after inclusion)
- In the inclusion, the measure of the retinal thickness with OCT (Optical Coherence Tomography)(10 weeks after inclusion)
- The measure of the evolution of the plasmatic rate of zeaxanthin after10 weeks of supplementation(10 weeks after inclusion)
- The measure of the macular pigment density before supplementation in 3, 6, 8, and 10 weeks of supplementation and after 4 weeks of stop by three methods: the sensibility in colours and two methods of autofluorescence(10 weeks after inclusion)
- In the inclusion, the measure of the visual acuity and the examination of the fundus oculi.(10 weeks after inclusion)