Carotenoid Supplementation and Retinal Health in Healthy Adults

Effect of Carotenoid Supplementation on Retinal Health: An Evaluation of Macular Structure and Function in Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: other; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aditi Deshpande; Phone Number: 503-352-2289; Email: aditi_1316@pacificu.edu

Study Locations

• United States
  • Oregon
    • Forest Grove, Oregon, United States, 97116
      • Recruiting
      • Pacific University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Dietary supplement: Placebo; 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.
Experimental: Treatment- Carotenoid Supplementation	Dietary supplement: other; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Macular Pigment Optical Density (MPOD) in Density Units Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Fundus Autofluorescence (FAF) Brightness in Pixels Over 3 Months	From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Central Retinal Thickness in Micrometers (µm) Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Macular Vascular and Choriocapillaris Density in Percentage (%) Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Skin Carotenoid Levels measured as Score Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Memory Test Measured as Percentage (%) of Correct Responses Over 3 Months	From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Contrast Sensitivity in Log Contrast Units Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Photostress Recovery Time (PRT) Measured in Seconds Over 3 Months	From enrollment to the end of treatment at 3 months
Change From Baseline in Mean Ocular Perfusion Pressure (OPP) Measured in Millimeters of Mercury (mmHg) Over 3 Months	From enrollment to the end of treatment at 3 months

Collaborators and Investigators

• Sponsor: Pacific University
• Collaborators: MacuHealth

Publications and helpful links

Helpful Links

• The web page compiles information on scientific and clinical studies related to macular carotenoid supplements, nutrition, retinal health, and eye function.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB 132-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared at this time due to ongoing analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No