Carotenoid Supplementation and Retinal Health in Healthy Adults

Pacific University

Status

Enrolling

Conditions

Healthy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: other

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07314411

IRB 132-24

Details and patient eligibility

About

The purpose of this research is to evaluate the effect of oral dietary carotenoid supplements on various aspects of retinal health. This includes assessing its impact on macular pigment optical density (MPOD), which is a protective feature of retinal health in reducing lipofuscin (retinal waste) accumulation in the retina.

Our goal is to investigate the protective role of this oral carotenoid supplement on the macular structure, measured as retinal thickness, macular blood vessel density, choriocapillaris density and ocular perfusion pressure (defined as the difference between blood pressure and eye pressure) as well as evaluating visual functions such as contrast sensitivity (the ability to perceive less bold objects ) and photostress recovery time (the minimum time for a person to read the lowest level on an eye chart after shining a light in front of the eye for several seconds). This study will also investigate the relationship between skin carotenoid level and ocular carotenoid level, using a non-invasive finger measurement. Also, we want to explore the effect of carotenoid supplementation on cognitive function in terms of working memory. Understanding how this supplementation impacts all these markers is crucial for enhancing our knowledge of the potential health benefits of carotenoids in improving dietary assessment methods.

This study takes 3 visits. Participants will provide written informed consent on the first visit after reviewing the study procedures, potential risks, benefits, confidentiality measures, and their right to withdraw. Then they will undergo a comprehensive history-taking and complete a validated questionnaire to screen for sensitivity to light, as well as a diet questionnaire. Following this, participant will have non-invasive testing, requiring no eye drops or dyes. This involves measurement of contrast sensitivity (CS), photostress recovery, MPOD, blood pressure (BP), intraocular pressure (IOP), skin carotenoid level, retinal thickness and vascular measures using an optical coherence tomographer (OCT), lipofuscin levels using fundus autofluorescence (FAF) pictures and cognitive function assessment of working memory using a computerized 2- back test. Each participant will then be provided with a commercially-made softgel capsule (either carotenoid supplement or placebo containing only the inactive ingredients) in unmarked bottles and instructed to take one softgel capsule daily with a meal for 3 months. Follow-up visits will take place for 1 month and 3 months, during which the same measurements mentioned above will be repeated.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age between 18-75 years
Monocular best corrected visual acuity (BCVA) of 20/20 or better
Eye pressure between 8 and 22 mm of Hg (will be screened in study if needed)
Ability to provide informed consent
Access to the Internet

Exclusion criteria

History of or currently active eye diseases or systemic disease
History of refractive surgery or ocular surgery
Currently pregnant, nursing or planning to become pregnant during the study period
Known allergy to any study active or inactive ingredient
Current supplementation with any components of MacuHealth or placebo softgel capsules
Drugs that may interact with absorption of fat-soluble vitamins/carotenoids especially orlistat and bile acid sequestrants (i.e., colestyramine, fat-free substitutes such as Olestra, beta-carotene, and vitamin E), or antidiabetic drugs