Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2025
CompletedFirst Posted
Study publicly available on registry
May 11, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedSeptember 24, 2025
September 1, 2025
8 months
May 2, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotenoid concentration
Change in skin carotenoid concentration over supplementation vs. placebo exposure durations.
6 months
Study Arms (2)
MacuHealth Supplementation
ACTIVE COMPARATORLutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vision Source
Kansas City, Missouri, 64111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Placebo vs. Vitamin will be masked to patient and investigator
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2025
First Posted
May 11, 2025
Study Start
June 1, 2025
Primary Completion
January 15, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09