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

August 28, 2026 updated by: Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Other Names:
  • MacuHealth
Active Comparator: MacuHealth Supplementation
Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation
Other Names:
  • MacuHealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotenoid concentration
Time Frame: 6 months
Change in skin carotenoid concentration over supplementation vs. placebo exposure durations.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

Collaborators

MacuHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 29, 2026

Study Completion (Estimated)

December 29, 2026

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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