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临床试验/NCT00527553
NCT00527553已完成不适用

The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Measurable macular pigment

研究概览

简要总结

Age-related macula degeneration (AMD, encompassing both dry and wet form), the late stage of Age-related maculopathy (ARM), is the leading cause of blindness in many developed countries in older persons (usually over 60 years of age). Visual compromise rises exponentially after the age of 70 with a 5-year incidence of around 1%. Studies have shown a possible protective effect of lutein on progression of AMD, where visual acuity improves after increased lutein intake. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years is over 50% with a 2.1-2.8% overall incidence in the study population.

Blue light hazard (excitation peak 440 nm) was shown to have a major impact on photoreceptor and RPE function inducing photochemical damage and cellular apoptosis, leading to retinal degeneration in an animal study. The current belief is that lutein accumulated in the macular region helps in the prevention of blindness by absorbing blue light and protecting the retina from oxidative stress. With the lipid matrix of the egg yolk being a proven vehicle for the efficient absorption of dietary lutein, it might be possible to increase plasma levels of lutein to therapeutic levels and control or prevent AMD. This, the investigators hope, will be accomplished by means of filtering out harmful blue light and the scavenging of free radicals by lutein and zeaxanthin.

详细描述

This will be a randomized placebo-controlled trial. The total study time will be two years of which 3 months are actual trial and follow-up time. Every individual will have 3 measuring points at set intervals. At every measuring point (days 1, 45 and 90), these subjects will undergo 6 different non-invasive measuring techniques. These are the mean visual acuity test using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity using the Pelli-Robson chart, Scanning Laser Ophthalmoscope (SLO), Optical Coherence Tomography (OCT) and Heterochromatic Flicker Photometry (HFP) and the Reflectometer. A questionnaire will be taken at the beginning of the trail. The invasive part of the study involves blood sampling at all three times, measuring the serum concentration of lutein, zeaxanthin, omega-3 and lipoprotein using the HPLC analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •No history of ARM or AMD
  • •18 years and older
  • •Non-smoker
  • •No ocular media opacity
  • •Uses no nutritional supplements containing Lutein, Zeaxanthin or Omega-3
  • •BMI < 30
  • •No known cardiovascular disease

排除标准

  • •Other known eye disease
  • •Known lipid metabolism disease
  • •Blood lipid level modifiers (e.g., Statin)
  • •Known allergy to eggs or egg products

研究组 & 干预措施

A

Experimental

daily consumption of a regular egg

干预措施: not enriched egg (Dietary Supplement)

D

Experimental

daily egg product from enriched eggs

干预措施: egg product from enriched eggs (Dietary Supplement)

E

No Intervention

control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.

C

Experimental

daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.

干预措施: zeaxanthin (Dietary Supplement)

B

Experimental

daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.

干预措施: lutein (Dietary Supplement)

结局指标

主要结局

Measurable macular pigment

时间窗: 3 months

次要结局

  • Plasma Lutein and zeaxanthin concentrations, lipid profile(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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