FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

Age Related Macular Degeneration Clinical Trial

— FLOS  

Official title:

FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761341
• Other study ID #: FLOS Study
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: October 22, 2019

Study information

• Verified date: January 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• NUTROF TOTAL
1 per day over a course of 3 months

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPOD (macular pigment optical Density)	Method to detect changes in macular pigment optic Density using dual wavelength autofluorescence	6 Months
Primary	Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO)	Retinal Autofluorescence lifetimes	6 Months
Primary	Macular pigment screener (MPS) II	Screening Method to detect changes in macular pigment optic Density using heterochromatic flicker photometry	6 Months
Secondary	Contrast sensitivity	Using Pelli-Robson charts	6 Months
Secondary	Visual acuity	Visual acuity using ETDRS charts	6 Months
Secondary	Serum Lutein concentration		6 Months
Secondary	Stool Analysis namely taxonomic and functional characterization of gut microbiota		6 Months