HealthyNCT07314411
Carotenoid Supplementation and Retinal Health in Healthy Adults
A study testing other in people with Healthy, run by Pacific University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- other
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pacific University
Forest Grove, Oregon, 97116
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- other, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment- Carotenoid Supplementation | Experimental | Not described Receives: Dietary Supplement: other |
| Placebo | Experimental | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Macular Pigment Optical Density (MPOD) in Density Units Over 3 Months
Measured: From enrollment to the end of treatment at 3 months
Change From Baseline in Fundus Autofluorescence (FAF) Brightness in Pixels Over 3 Months
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (4)
Change From Baseline in Central Retinal Thickness in Micrometers (µm) Over 3 Months
Measured: From enrollment to the end of treatment at 3 months
Change From Baseline in Macular Vascular and Choriocapillaris Density in Percentage (%) Over 3 Months
Measured: From enrollment to the end of treatment at 3 months
Change From Baseline in Skin Carotenoid Levels measured as Score Over 3 Months
Measured: 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
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- MacuHealth
- Responsible party
- Principal investigator, Aditi Deshpande, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314411
- Sponsor's protocol ID
- IRB 132-24
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared at this time due to ongoing analyses.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carotenoid Supplementation on Retinal Health: An Evaluation of Macular Structure and Function in Healthy Adults
- ClinicalTrials.gov ID
- NCT07314411
- Acronym / sponsor ID
- IRB 132-24
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Collaborators
- MacuHealth
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment- Carotenoid Supplementation | Experimental | Dietary Supplement: other |
| Placebo | Experimental | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otherParticipant 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. | Dietary supplement | Treatment- Carotenoid Supplementation |
| PlaceboParticipant 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. | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- The web page compiles information on scientific and clinical studies related to macular carotenoid supplements, nutrition, retinal health, and eye function.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared at this time due to ongoing analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing other in people with Healthy, run by Pacific University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aditi Deshpande (503-352-2289, aditi_1316@pacificu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.