Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761341
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2020-11-24
Brief Title:
FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOS
Brief Summary:
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
Detailed Description:
The human macula is a small area of the retina responsible for central vision The yellow macular pigment contains three carotenoids lutein 3R3R6R-lutein zeaxanthin 3R3R-zeaxanthin and meso-zeaxanthin 3R3Smeso-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 ClinicalTrialsgov 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
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 ClinicalTrialsgov 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None