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Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study

Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965426
Enrollment
60
Registered
2025-05-11
Start date
2025-06-01
Completion date
2026-12-29
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degenerative Disease

Keywords

Carotenoids, Macular degeneration, MacuHealth

Brief 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.

Interventions

OTHERLutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Sponsors

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
Lead SponsorOTHER
MacuHealth
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Placebo vs. Vitamin will be masked to patient and investigator

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Carotenoid concentration6 monthsChange in skin carotenoid concentration over supplementation vs. placebo exposure durations.

Countries

United States

Contacts

CONTACTCrystal Remington, OD
drremington@vseyecare.com8165319100
CONTACTRyan Powell, OD
drpowell@vseyecare.com8165319100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026