Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07314411

Carotenoid Supplementation and Retinal Health in Healthy Adults

Led by Pacific University · Updated on 2026-01-06

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

P

Pacific University

Lead Sponsor

M

MacuHealth

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Carotenoid Supplementation and Retinal Health in Healthy Adults

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Monocular best corrected visual acuity of 20/20 or better
  • Eye pressure between 8 and 22 mm of Hg (to be screened if needed)
  • Ability to provide informed consent
  • Access to the Internet
Not Eligible

You will not qualify if you...

  • History of or active eye diseases or systemic diseases
  • History of refractive or ocular surgery
  • Currently pregnant, nursing, or planning pregnancy during the study
  • Allergy to any active or inactive study ingredient
  • Current use of supplements containing MacuHealth or placebo ingredients
  • Use of drugs that may affect absorption of fat-soluble vitamins or carotenoids, including orlistat, bile acid sequestrants, beta-carotene, vitamin E, or certain antidiabetic drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pacific University

Forest Grove, Oregon, United States, 97116

Actively Recruiting

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Research Team

A

Aditi Deshpande

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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