Carotenoid Supplementation and Retinal Health in Healthy Adults
NCT ID: NCT07314411
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-04-01
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Carotenoid Supplementation and Normal Ocular Health
NCT02147171
Investigation of the Genetic and Environmental Determinants of MP Including Response to Supplementation
NCT01778231
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
NCT00879671
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
NCT01048476
Effects of Lutein on Visual Function
NCT03113864
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment- Carotenoid Supplementation
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MacuHealth
INDUSTRY
Pacific University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aditi Deshpande
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pacific University
Forest Grove, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
The web page compiles information on scientific and clinical studies related to macular carotenoid supplements, nutrition, retinal health, and eye function.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB 132-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.