Clinical trial NCT04761341: FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Official title: FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: MPOD (macular pigment optical Density)
timeFrame: 6 Months
measure: Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)
timeFrame: 6 Months
measure: Macular pigment screener (MPS) II
timeFrame: 6 Months
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 6 Months
measure: Visual acuity
timeFrame: 6 Months
measure: Serum Lutein concentration
timeFrame: 6 Months
measure: Stool Analysis namely taxonomic and functional characterization of gut microbiota
timeFrame: 6 Months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
Study officials:
affiliation: Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
name: Martin Zinkernagel, MD, PHD
role: STUDY_CHAIR
References: