FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment
FLOS
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2019
CompletedFirst Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedJanuary 26, 2023
January 1, 2023
1.4 years
November 24, 2020
January 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Contrast sensitivity
6 Months
Visual acuity
6 Months
Serum Lutein concentration
6 Months
Stool Analysis namely taxonomic and functional characterization of gut microbiota
6 Months
Study Arms (2)
AMD
EXPERIMENTALhealthy control
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subject must be willing to give written informed consent
- Probands 18 years of age or greater
- Both eyes will be assessed in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 37344061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin Zinkernagel, MD, PHD
Department of Ophthalmology, Inselspital, Bern University Hostpital, University of Bern, Bern, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
February 18, 2021
Study Start
June 1, 2018
Primary Completion
October 22, 2019
Study Completion
October 22, 2019
Last Updated
January 26, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share