Recruiting

Carotenoid Supplement

Sponsor:

Pacific University

Code:

NCT07314411

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

other

Placebo

Study Details

Brief summary:

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

Healthy

Study ID

NCT07314411

Start date

Apr 1, 2025

Status verified date

Jan, 2026

Completion date

May, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Treatment- Carotenoid Supplementation

experimental: Placebo

Interventions

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.

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.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Pacific University

Recruiting

Forest Grove, Oregon, United States, 97116

More Information

Sponsor

Pacific University

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pacific University on 2026-01-06.