Carotenoid Supplementation and Retinal Health in Healthy Adults

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPacific University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • other

    Dietary supplement

    Participant will 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.

  • Placebo

    Dietary supplement

    Participant will 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Treatment- Carotenoid SupplementationExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Macular Pigment Optical Density (MPOD) in Density Units Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
2

Change From Baseline in Fundus Autofluorescence (FAF) Brightness in Pixels Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

1

Change From Baseline in Central Retinal Thickness in Micrometers (µm) Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
2

Change From Baseline in Macular Vascular and Choriocapillaris Density in Percentage (%) Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
3

Change From Baseline in Skin Carotenoid Levels measured as Score Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
4

Change From Baseline in Memory Test Measured as Percentage (%) of Correct Responses Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months

Other outcomes

1

Change From Baseline in Contrast Sensitivity in Log Contrast Units Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
2

Change From Baseline in Photostress Recovery Time (PRT) Measured in Seconds Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months
3

Change From Baseline in Mean Ocular Perfusion Pressure (OPP) Measured in Millimeters of Mercury (mmHg) Over 3 Months

Time frame
From enrollment to the end of treatment at 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pacific University

Lead sponsor

MacuHealth

Collaborator