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

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

Status: Not yet enrolling

Conditions: Macular Degenerative Disease

Treatments: Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06965426

VSE001

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

MacuHealth Supplementation

Active Comparator group

Description:

Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Treatment:

Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation