FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

NCT ID: NCT04761341

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-10-22

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.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

AMD

Group Type: EXPERIMENTAL

NUTROF TOTAL

Intervention Type: DRUG

1 per day over a course of 3 months

healthy control

Group Type: ACTIVE_COMPARATOR

NUTROF TOTAL

Intervention Type: DRUG

1 per day over a course of 3 months

Interventions

NUTROF TOTAL

1 per day over a course of 3 months

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Zinkernagel, MD, PHD

Role: STUDY_CHAIR

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

Locations

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

Bern, , Switzerland

Countries

Switzerland

References

Jaggi D, Solberg Y, Dysli C, Lincke J, Habra O, Wyss A, Wolf S, Zinkernagel M. Fluorescence lifetime imaging ophthalmoscopy and the influence of oral lutein/zeaxanthin supplementation on macular pigment (FLOS) - A pilot study. Clin Nutr ESPEN. 2023 Aug;56:127-134. doi: 10.1016/j.clnesp.2023.05.009. Epub 2023 May 15.

Reference Type: DERIVED

PMID: 37344061 (View on PubMed)

Other Identifiers

FLOS Study

Identifier Type: -

Identifier Source: org_study_id