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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
NUTROF TOTAL
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AMD

healthy control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Contrast sensitivity
Using Pelli-Robson charts
Visual acuity
Visual acuity using ETDRS charts
Serum Lutein concentration
Stool Analysis namely taxonomic and functional characterization of gut microbiota

Full Information

First Posted
November 24, 2020
Last Updated
January 24, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04761341
Brief Title
FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Acronym
FLOS
Official Title
FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
October 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMD
Arm Type
Experimental
Arm Title
healthy control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NUTROF TOTAL
Intervention Description
1 per day over a course of 3 months
Primary Outcome Measure Information:
Title
MPOD (macular pigment optical Density)
Description
Method to detect changes in macular pigment optic Density using dual wavelength autofluorescence
Time Frame
6 Months
Title
Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)
Description
Retinal Autofluorescence lifetimes
Time Frame
6 Months
Title
Macular pigment screener (MPS) II
Description
Screening Method to detect changes in macular pigment optic Density using heterochromatic flicker photometry
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Contrast sensitivity
Description
Using Pelli-Robson charts
Time Frame
6 Months
Title
Visual acuity
Description
Visual acuity using ETDRS charts
Time Frame
6 Months
Title
Serum Lutein concentration
Time Frame
6 Months
Title
Stool Analysis namely taxonomic and functional characterization of gut microbiota
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Zinkernagel, MD, PHD
Organizational Affiliation
Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

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