Carotenoid Measurements for Macular Pigmentation

Overseen By Kelliann Farnsworth

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Under age 7

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. The investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue. A secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Carotenoid measurements, Lutein, Zeaxanthin, Xanthophyll, Luteol for macular pigmentation?

Research shows that supplementing with lutein and zeaxanthin, which are types of carotenoids, can improve macular pigment density and visual performance, especially in conditions like age-related macular degeneration. This suggests that these components may help maintain or improve eye health by enhancing the density of the macular pigment, which is important for protecting the eyes and improving vision. ^{1 2 3 4 5}

Is it safe to take carotenoid supplements like lutein and zeaxanthin?

Research shows that supplementation with carotenoids such as lutein, zeaxanthin, and meso-zeaxanthin is generally safe for humans, as studies have specifically investigated their safety. ^{1 4 5 6 7}

How does the treatment for macular pigmentation differ from other treatments?

This treatment is unique because it involves measuring the levels of carotenoids like lutein and zeaxanthin in the eye, which are important for eye health and may help prevent vision loss. Unlike other treatments, it focuses on non-invasive measurement techniques to assess macular pigment density, which can help identify individuals at risk for vision problems. ^{7 8 9 10 11}

Research Team

Paul Bernstein, MD

Principal Investigator

University of Utah Moran Eye Center

Eligibility Criteria

This trial is for anyone aged 7 or older who's getting a routine eye exam at the Moran Eye Center. It includes those with adult vitelliform dystrophy, which can look like early age-related macular degeneration but starts in adulthood.

Inclusion Criteria

I have been diagnosed with adult vitelliform dystrophy.

I am 7 years or older and get regular eye exams at the Moran Eye Center.

Exclusion Criteria

I am older than 7 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Measurement

Participants have carotenoid levels measured in the eye, skin, and/or blood

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after measurements

4 weeks

Treatment Details

Interventions

• Carotenoid measurements

Trial Overview The study aims to understand how nutrition affects our eyes and skin by testing non-invasive ways to measure carotenoid levels in these tissues. Part of the study also looks at carotenoid levels in blood samples from some participants.

Participant Groups

Group I: Carotenoid measurements Experimental Treatment 1 Intervention

Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

In a study of 67 subjects with early age-related macular degeneration (AMD), different macular carotenoid formulations significantly increased macular pigment (MP) over 3 years, particularly in groups that included meso-zeaxanthin (MZ).

The group receiving the formulation with MZ showed notable improvements in contrast sensitivity (CS), indicating that MZ may enhance visual function in early AMD, while no significant changes in best-corrected visual acuity (BCVA) or progression to advanced AMD were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained supplementation and monitored response with differing carotenoid formulations in early age-related macular degeneration. Akuffo, KO., Nolan, JM., Howard, AN., et al.[2022]

In a study involving patients with retinitis pigmentosa and Usher syndrome, macular pigment (MP) density was found to be similar to that of normal subjects, but lower MP was associated with more severe disease expression.

After 6 months of lutein supplementation, while serum lutein levels increased, only about half of the patients showed a significant increase in MP, and there was no change in central vision, indicating that while lutein may help some patients, its overall impact on vision remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular pigment and lutein supplementation in retinitis pigmentosa and Usher syndrome. Aleman, TS., Duncan, JL., Bieber, ML., et al.[2022]

In a study of 107 healthy volunteers, macular pigment optical density (MPOD) was found to significantly correlate with plasma levels of lutein and zeaxanthin, suggesting these nutrients may play a role in eye health.

MPOD also showed a significant correlation with total plasma omega-3 polyunsaturated fatty acids (PUFAs), particularly docosapentaenoic acid (DPA), indicating that omega-3 fatty acids may also contribute to macular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of macular pigment density with plasma ω-3 fatty acids: the PIMAVOSA study. Delyfer, MN., Buaud, B., Korobelnik, JF., et al.[2015]

Supplementation with a formulation containing high doses of meso-zeaxanthin, along with lutein and zeaxanthin, significantly increased macular pigment optical density and improved visual performance in subjects with early age-related macular degeneration over a 12-month period.

Group 3, which received the highest dose of meso-zeaxanthin, showed the most notable improvements in letter contrast sensitivity across various spatial frequencies, indicating that this combination may be particularly effective for enhancing visual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation with three different macular carotenoid formulations in patients with early age-related macular degeneration. Sabour-Pickett, S., Beatty, S., Connolly, E., et al.[2018]

Supplementation with a formulation containing meso-zeaxanthin (MZ) significantly increased macular pigment optical density (MPOD) and improved visual performance in subjects, while other formulations without MZ did not show these benefits.

In a study of 36 participants over 6 months, only the group receiving the MZ-containing supplement demonstrated significant improvements in visual acuity and contrast sensitivity, highlighting the potential importance of MZ in eye health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of macular pigment augmentation on visual performance using different carotenoid formulations. Loughman, J., Nolan, JM., Howard, AN., et al.[2012]

In a study involving 44 healthy participants, supplementation with meso-zeaxanthin, lutein, and zeaxanthin significantly increased serum levels of these carotenoids and improved macular pigment optical density (MPOD) after 6 months.

The supplementation was found to be safe, with no adverse clinical effects reported, although some participants had elevated cholesterol levels at baseline that were not related to the supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation with all three macular carotenoids: response, stability, and safety. Connolly, EE., Beatty, S., Loughman, J., et al.[2018]

In a study of 112 patients with early age-related macular degeneration (AMD), supplementation with lutein and zeaxanthin significantly increased macular pigment optical density (MPOD) after 2 years, indicating a potential protective effect on the retina.

Lutein supplementation also improved retinal sensitivity, as measured by multifocal electroretinogram and microperimeter assessments, suggesting that these supplements may enhance visual function in early AMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes following supplementation with lutein and zeaxanthin in retinal function in eyes with early age-related macular degeneration: a randomised, double-blind, placebo-controlled trial. Huang, YM., Dou, HL., Huang, FF., et al.[2015]

Lutein and zeaxanthin, two xanthophyll carotenoids, are important for maintaining the health of the human macula, which is crucial for vision.

Non-invasive methods to measure macular pigment levels can help identify individuals at risk for age-related macular degeneration, allowing for early intervention to prevent vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of measurement of macular carotenoid pigment optical densities and distributions in age-related macular degeneration and other retinal disorders. Bernstein, PS., Delori, FC., Richer, S., et al.[2021]

The macular pigment reflectometer (MPR) effectively measures macular pigment optical density (MPOD) and carotenoid densities (lutein and zeaxanthin) at different retinal locations, showing that MPOD decreases as you move away from the fovea.

The study found that there is a higher concentration of zeaxanthin in the central fovea compared to lutein, and the ratio of lutein to zeaxanthin changes with retinal eccentricity, indicating a complex distribution of these carotenoids in the eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of Carotenoids in Perifovea using the Macular Pigment Reflectometer. Sanabria, JC., Bass, J., Spors, F., et al.[2020]

Lutein and zeaxanthin, important carotenoids in the retina, are believed to protect the macular pigment (MP), leading to increased interest in noninvasive measurement methods for these compounds.

The study highlights that different measurement techniques can lead to variations in the assessment of MP, emphasizing the need for standardized methods to ensure accurate spectral absorption curves that align with ex vivo measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the validity of in vivo methods of measuring human macular pigment optical density. Hammond, BR., Wooten, BR., Smollon, B.[2019]

After eight weeks of daily supplementation with a carotenoid formulation, there were significant increases in serum levels of meso-zeaxanthin (MZ) and lutein (L), indicating effective absorption of these carotenoids.

The study also found significant improvements in macular pigment optical density (MPOD) after just two weeks, particularly in subjects with atypical MPOD profiles, suggesting that the formulation can help restore normal macular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation of macular pigment following supplementation with all three macular carotenoids: an exploratory study. Connolly, EE., Beatty, S., Thurnham, DI., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Sustained supplementation and monitored response with differing carotenoid formulations in early age-related macular degeneration. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Macular pigment and lutein supplementation in retinitis pigmentosa and Usher syndrome. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Association of macular pigment density with plasma ω-3 fatty acids: the PIMAVOSA study. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Supplementation with three different macular carotenoid formulations in patients with early age-related macular degeneration. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of macular pigment augmentation on visual performance using different carotenoid formulations. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Supplementation with all three macular carotenoids: response, stability, and safety. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Changes following supplementation with lutein and zeaxanthin in retinal function in eyes with early age-related macular degeneration: a randomised, double-blind, placebo-controlled trial. [2015]

8. England pubmed.ncbi.nlm.nih.gov

The value of measurement of macular carotenoid pigment optical densities and distributions in age-related macular degeneration and other retinal disorders. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Measurement of Carotenoids in Perifovea using the Macular Pigment Reflectometer. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of the validity of in vivo methods of measuring human macular pigment optical density. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Augmentation of macular pigment following supplementation with all three macular carotenoids: an exploratory study. [2018]