Lutein, zeaxanthin, and meso-zeaxanthin supplements to raise skin carotenoid levels
Official title: Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
Run by Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, · NCT06965426 · Data updated 2026-11-12
This trial will test whether taking MacuHealth (lutein, zeaxanthin, and meso‑zeaxanthin) increases skin carotenoid levels in adults with macular degeneration.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | October 29, 2026 |
| Study ends | December 29, 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT06965426 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are non-smoking adults aged 18–50 with macular degeneration who are not pregnant or breastfeeding, have BMI ≤30, and are not currently taking lutein/zeaxanthin supplements.
✕Probably not a fit
Smokers, pregnant or breastfeeding people, those with BMI over 30, people with uncontrolled systemic diseases, or current users of MacuHealth or similar supplements are unlikely to benefit or are excluded from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled crossover trial enrolls adults with macular degeneration and compares 12 weeks of MacuHealth supplementation to 12 weeks of placebo, with each participant receiving both treatments over a six-month period. Skin carotenoid concentration is measured at baseline and during each treatment period to track changes associated with supplementation. Key exclusions include current smokers, pregnancy or breastfeeding, BMI over 30, uncontrolled systemic diseases, and current or prior use of similar supplements. The trial is sponsored by a private eyecare practice in collaboration with MacuHealth and is conducted at a single site in Kansas City.
Why it matters
Potential benefit: If successful, the supplement could raise tissue carotenoid levels that may reflect improved ocular carotenoid status and support macular health.
How similar studies have gone: Prior clinical work has shown that lutein and zeaxanthin supplements can raise retinal and skin carotenoid levels, so this approach builds on existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
-
Vision Source
Kansas City, Missouri, United States Recruiting
Study contacts
- Study coordinator: Crystal Remington, OD
- Email: drremington@vseyecare.com
- Phone: 8165319100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.