FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment (FLOS)

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 Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Drug: NUTROF TOTAL

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMD	Drug: NUTROF TOTAL; 1 per day over a course of 3 months
Active Comparator: healthy control	Drug: NUTROF TOTAL; 1 per day over a course of 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPOD (macular pigment optical Density)	Method to detect changes in macular pigment optic Density using dual wavelength autofluorescence	6 Months
Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)	Retinal Autofluorescence lifetimes	6 Months
Macular pigment screener (MPS) II	Screening Method to detect changes in macular pigment optic Density using heterochromatic flicker photometry	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	Using Pelli-Robson charts	6 Months
Visual acuity	Visual acuity using ETDRS charts	6 Months
Serum Lutein concentration		6 Months
Stool Analysis namely taxonomic and functional characterization of gut microbiota		6 Months

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Martin Zinkernagel, MD, PHD, Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: FLOS Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No