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

NCT ID: NCT06965426

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-01

Brief Summary

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To compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or MacuHealth and comparing that to a 12 week crossover evaluation.

Detailed Description

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Conditions

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Macular Degenerative Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Placebo vs. Vitamin will be masked to patient and investigator

Study Groups

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MacuHealth Supplementation

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Group Type ACTIVE_COMPARATOR

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Intervention Type OTHER

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Intervention Type OTHER

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Interventions

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Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Intervention Type OTHER

Other Intervention Names

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MacuHealth

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MacuHealth

INDUSTRY

Sponsor Role collaborator

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vision Source

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Crystal Remington, OD

Role: CONTACT

8165319100

Ryan Powell, OD

Role: CONTACT

8165319100

Facility Contacts

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Crystal Remington Remington, OD

Role: primary

816-531-9100

Ryan Powell Powell, OD

Role: backup

8164764017

Other Identifiers

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VSE001

Identifier Type: -

Identifier Source: org_study_id

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