Macular Degenerative DiseaseNCT06965426
Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
A study testing Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation in people with Macular Degenerative Disease, run by Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, at 1 site in United States.
Trial summary
To compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or MacuHealth and comparing that to a 12 week crossover evaluation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degenerative Disease
- What is being tested?
- Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 29 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients 18-50 years old of any sex and any race.
- Willing to comply with the protocol instructions.
- Has read (or has had read to), understood, and signed an Informed Consent.
Who cannot join
- Current Smoker
- Pregnant, plan to become pregnant or breastfeeding
- History of any non-controlled disease states including diabetes, cancer, heart diseases ETC (we need to confirm this with previous protocols) BMI greater than 30
- Currently taking MacuHealth or similar supplements or previous use
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
Vision Source
Kansas City, Missouri, 64111
Crystal Remington Remington, OD, 816-531-9100, drremington@vseyecare.com
Ryan Powell Powell, OD, 8164764017, drpowell@vseyecare.com
About this study
To compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or MacuHealth and comparing that to a 12 week crossover evaluation.
- Conditions
- Macular Degenerative Disease
- Being tested
- Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
- Keywords
- Carotenoids, Macular degeneration, MacuHealth
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein, Zeaxanthin, and Meso-Zeaxanthin SupplementationOther
Also called MacuHealth
Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
| Study group | Role | What they receive |
|---|---|---|
| MacuHealth Supplementation | Active comparator | Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation Receives: Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation |
| Placebo | Placebo comparator | Placebo Receives: Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotenoid concentration
Change in skin carotenoid concentration over supplementation vs. placebo exposure durations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025
- Primary completion29 Oct 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degenerative DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
- Sponsor type
- University, hospital or other
- Collaborators
- MacuHealth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965426
- Sponsor's protocol ID
- VSE001
- Status last verified
- Aug 2026
- First submitted
- 2 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT06965426
- Acronym / sponsor ID
- VSE001
- Conditions
- Macular Degenerative Disease
- Keywords
- Carotenoids, Macular degeneration, MacuHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,University, hospital or other
- Collaborators
- MacuHealth
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 11 May 2025 (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.
To compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or MacuHealth and comparing that to a 12 week crossover evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MacuHealth Supplementation | Active comparator | Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin SupplementationLutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation |
| Placebo | Placebo comparator | Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin SupplementationPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 18-50 years old of any sex and any race.
- Willing to comply with the protocol instructions.
- Has read (or has had read to), understood, and signed an Informed Consent.
Key exclusion criteria (4 listed)
- Current Smoker
- Pregnant, plan to become pregnant or breastfeeding
- History of any non-controlled disease states including diabetes, cancer, heart diseases ETC (we need to confirm this with previous protocols) BMI greater than 30
- Currently taking MacuHealth or similar supplements or previous use
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 |
|---|---|---|
| Lutein, Zeaxanthin, and Meso-Zeaxanthin SupplementationAlso: MacuHealthLutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation | Other | MacuHealth Supplementation, Placebo |
Primary outcome
Carotenoid concentration
Time frame: 6 months
Change in skin carotenoid concentration over supplementation vs. placebo exposure durations.
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation in people with Macular Degenerative Disease, run by Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, 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 3 inclusion and 4 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 1 Sep 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. Some participants in this study may receive a placebo. 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 Crystal Remington, OD (8165319100, drremington@vseyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotenoid concentration (time frame: 6 months). 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 1 Sep 2026.