Lutein, zeaxanthin, and meso-zeaxanthin supplements to raise skin carotenoid levels
Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
This trial will test whether taking MacuHealth (lutein, zeaxanthin, and meso‑zeaxanthin) increases skin carotenoid levels in adults with macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06965426 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior clinical work has shown that lutein and zeaxanthin supplements can raise retinal and skin carotenoid levels, so this approach builds on existing evidence.
Eligibility criteria
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 this trial is running
Kansas City, Missouri
- Vision Source — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Crystal Remington, OD
- Email: drremington@vseyecare.com
- Phone: 8165319100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.