60 Participants Needed

Lutein, Zeaxanthin, and Meso-Zeaxanthin for Skin Carotenoid Levels

CR
RP
Overseen ByRyan Powell, OD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the effectiveness of certain supplements—specifically Lutein, Zeaxanthin, and Meso-Zeaxanthin, nutrients often found in leafy greens—in improving skin carotenoid levels over 12 weeks. Participants will take either these supplements or a placebo (a pill with no active ingredients) to observe any noticeable differences. The goal is to determine if these supplements can naturally boost skin health. Ideal candidates are adults who do not smoke, have no major uncontrolled health issues, and are not currently using similar supplements. As an unphased trial, this study offers participants the chance to contribute to foundational research on enhancing natural skin health.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently taking MacuHealth or similar supplements, you cannot participate.

Is there any evidence suggesting that Lutein, Zeaxanthin, and Meso-Zeaxanthin are likely to be safe?

Research has shown that lutein, zeaxanthin, and meso-zeaxanthin are generally safe for people. Studies found no harmful effects when taking high doses of lutein and zeaxanthin, up to 400 mg per kilogram of body weight per day, for 90 days. This suggests that the body can handle these substances well, even in large amounts.

Other research indicates that taking zeaxanthin orally is likely safe at doses up to 2 mg daily and possibly safe at higher doses, up to 10 mg daily. Most people can take it without issues.

Overall, these substances are well-tolerated and pose little risk when used as directed.12345

Why are researchers excited about this trial?

Researchers are excited about using Lutein, Zeaxanthin, and Meso-Zeaxanthin for skin carotenoid levels because these compounds are naturally occurring antioxidants known for protecting skin against damage from UV light and pollution. Unlike typical skin treatments that might involve topical creams or chemical ingredients, these nutrients are taken as a dietary supplement, offering a unique inside-out approach to skin health. This method could enhance skin protection and health by increasing internal carotenoid levels, potentially leading to better skin resilience and appearance.

What evidence suggests that Lutein, Zeaxanthin, and Meso-Zeaxanthin might be effective for improving skin carotenoid levels?

Research has shown that supplements containing lutein, zeaxanthin, and meso-zeaxanthin can increase carotenoid levels in the skin. In this trial, participants will receive either MacuHealth supplementation, which includes these nutrients, or a placebo. One study found that high doses of these nutrients improved skin carotenoid levels without causing serious side effects. Another study noted significant improvements in skin tone and brightness compared to a placebo. These findings suggest that the supplements might improve skin health by increasing carotenoid levels. Overall, the evidence supports their potential to enhance skin condition by boosting carotenoid concentration.678910

Are You a Good Fit for This Trial?

This trial is for individuals willing to follow study rules and who understand and agree to the study by signing an informed consent. Specific conditions like Age-Related Macular Degeneration are being targeted, but detailed exclusion criteria were not provided.

Inclusion Criteria

Has read (or has had read to), understood, and signed an Informed Consent
Willing to comply with the protocol instructions
I am between 18 and 50 years old.

Exclusion Criteria

Current Smoker
Pregnant, plan to become pregnant or breastfeeding
BMI greater than 30
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MacuHealth supplementation or placebo for 12 weeks

12 weeks

Crossover

Participants switch groups and receive the alternate treatment for another 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lutein, Zeaxanthin, and Meso-Zeaxanthin
Trial Overview The trial tests if supplements with Lutein, Zeaxanthin, and Meso-Zeaxanthin can change skin carotenoid levels over a period of 6 months. Participants will first receive either these supplements or a placebo for 12 weeks, then switch after a crossover evaluation.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: MacuHealth SupplementationActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

Lead Sponsor

MacuHealth

Industry Sponsor

Trials
2
Recruited
40+

Citations

Lutein, Zeaxanthin, and meso-Zeaxanthin - PubMed CentralThis relationship also held true with tissue carotenoid levels with maternal skin carotenoids correlating with infant skin carotenoids (r = 0.59, P < 0.001).
Effect of an antioxidant supplement containing high dose ...These results demonstrated the effectiveness of a high dose lutein/zeaxanthin supplement for MPOD volume and SC levels without serious adverse events.
The Effect of Lutein/Zeaxanthin Intake on Human Macular ...Daily doses of lutein/zeaxanthin between 5 and <20 mg increased MPOD by 0.04 units (95% CI: 0.02 to 0.07) among adults with healthy eyes (moderate strength of ...
Overall skin tone and skin-lightening-improving effects with ...Overall skin tone was significantly improved in the L/Zi group compared to placebo (P<0.0237), and luminance (L*) values were significantly increased in the L/ ...
Study Details | NCT06965426 | Effect of Lutein, Zeaxanthin ...Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study.
Zeaxanthin: Review of Toxicological Data and Acceptable ...The animal safety data for lutein and meso-zeaxanthin is notably less than what is available for zeaxanthin. EFSA has reviewed the available data for lutein [36] ...
Lutein, Zeaxanthin, and Meso-ZeaxanthinThe safety of various carotenoids and xanthophylls have been assessed as part of evaluations for use as food additives (see also Official ...
Safety assessment of lutein and zeaxanthin (Lutemax™ ...▻ In 90-day study, no adverse effects of lutein/zeaxanthin were noted at doses up to 400 mg/kg/day. ▻ In Ames assay, no mutagenic effects of lutein and ...
Zeaxanthin - Uses, Side Effects, and MoreWhen taken by mouth: Zeaxanthin is likely safe when used in doses up to 2 mg daily. It is possibly safe when taken in larger doses. Doses up to 10 mg daily seem ...
Lutein and ZeaxanthinAn observational study of approximately 7,000 adults reported that high levels of lutein and zeaxanthin were associated with lower incidence of AD mortality ...
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