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临床试验/NCT04761341
NCT04761341已完成4 期

FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
28
试验地点
1
主要终点
Macular pigment screener (MPS) II

研究概览

简要总结

To investigate the effects of lutein supplementation on macular pigment density using FLIO and MPOD measurements in patients with age-related macular degeneration and healthy subjects over a course of 6 months.

详细描述

The human macula is a small area of the retina responsible for central vision. The yellow macular pigment contains three carotenoids, lutein ((3R,3'R,6'R)-lutein), zeaxanthin ((3R,3'R)-zeaxanthin), and meso-zeaxanthin ((3R,3'S;meso)-zeaxanthin). The human body is unable to synthesize lutein and zeaxanthin, thus needs to be obtained from dietary sources such as green leafy vegetables and supplements. The function of the macular pigment is to act as a filter by absorbing blue light that may attenuate photochemical damage of the retina. Furthermore, it protects against light induced oxidative damage by functioning as an antioxidant; scavenging free radicals. A growing body of evidence has established a link between the concentrations of the macular pigment carotenoids, the macular pigment optical density (MPOD) levels, visual performance and the risk of macular degeneration.

The ability of the macular pigment to absorb or filter blue light can be measured as macular pigment optical density (MPOD), which is directly related to the quantity of lutein and zeaxanthin in the macula. Furthermore, preliminary data showed that macular pigment can be evaluated using Fluorescence lifetime imaging ophthalmoscopy (FLIO). In a previous study the investigators have shown that FLIO provides contrast for macular pigment in patients with AMD and healthy subjects.

The purpose of this study is to investigate the effects of oral lutein supplementation on macular pigment density using FLIO and MPOD measurements in healthy subjects and patients with age-related macular degeneration (AMD) over a course of 6 months. Furthermore, the investigators will assess whether compositional and functional alterations of the gut metagenome may be related to age-related macular degeneration, and the effects of lutein supplementation on the gut. In addition, to blood samples, stool samples will be analysed accordingly to the currently running study on "The role of the gut metagenome on the development of ophthalmic diseases" ClinicalTrials.gov Identifier: NCT02438111. Faecal analyses will provide insight to how oral lutein supplementation effects the gut microbiota and how it is influenced by serum lutein Levels.

Objective is to investigate the effects of lutein supplementation on macular pigment density using FLIO and MPOD measurements in patients with age-related macular degeneration and healthy subjects over a course of 6 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Subject must be willing to give written informed consent
  • Probands 18 years of age or greater
  • Both eyes will be assessed in the study

排除标准

  • Opacities of ocular media excluding detailed observation of the retina
  • Gastrointestinal diseases that could cause disturbance of dietary absorption
  • History of lutein supplementation
  • Allergy to lutein and zeaxanthin
  • Missing compliance

研究组 & 干预措施

AMD

Experimental

干预措施: NUTROF TOTAL (Drug)

healthy control

Active Comparator

干预措施: NUTROF TOTAL (Drug)

结局指标

主要结局

Macular pigment screener (MPS) II

时间窗: 6 Months

Screening Method to detect changes in macular pigment optic Density using heterochromatic flicker photometry

Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)

时间窗: 6 Months

Retinal Autofluorescence lifetimes

MPOD (macular pigment optical Density)

时间窗: 6 Months

Method to detect changes in macular pigment optic Density using dual wavelength autofluorescence

次要结局

  • Contrast sensitivity(6 Months)
  • Visual acuity(6 Months)
  • Serum Lutein concentration(6 Months)
  • Stool Analysis namely taxonomic and functional characterization of gut microbiota(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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