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FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761341
Acronym
FLOS
Enrollment
28
Registered
2021-02-18
Start date
2018-06-01
Completion date
2019-10-22
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

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 ((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.

Interventions

1 per day over a course of 3 months

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
MPOD (macular pigment optical Density)6 MonthsMethod to detect changes in macular pigment optic Density using dual wavelength autofluorescence
Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)6 MonthsRetinal Autofluorescence lifetimes
Macular pigment screener (MPS) II6 MonthsScreening Method to detect changes in macular pigment optic Density using heterochromatic flicker photometry

Secondary

MeasureTime frameDescription
Contrast sensitivity6 MonthsUsing Pelli-Robson charts
Stool Analysis namely taxonomic and functional characterization of gut microbiota6 Months
Visual acuity6 MonthsVisual acuity using ETDRS charts
Serum Lutein concentration6 Months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026