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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how nutrition affects the eye and skin by measuring carotenoid levels in these tissues. Carotenoids, nutrients found in fruits and vegetables, may impact eye health. The study will use non-invasive methods to assess these levels and examine their relationship to carotenoid levels in the blood for some participants. It seeks participants aged 7 years or older who are attending routine eye exams, particularly those with adult vitelliform dystrophy, a condition with eye lesions often mistaken for early macular degeneration. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of nutrition's impact on eye and skin health.

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 prior data suggests that these carotenoid measurement methods are safe?

Research has shown that measuring carotenoids, such as lutein and zeaxanthin, in the body links to positive health outcomes. Studies indicate that higher levels of these carotenoids in the blood can reduce the risk of age-related macular degeneration, a common eye disease, by 57%. Other research found that taking lutein and zeaxanthin improves vision by enhancing the ability to see in bright or glaring light.

No specific data exists on negative effects from measuring carotenoids. However, since carotenoids are nutrients found in many fruits and vegetables, they are generally considered safe. Studies on carotenoid levels in the eye, skin, or blood have reported no serious side effects. Overall, these measurements are well-tolerated and pose minimal safety concerns based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about carotenoid measurements for macular pigmentation because they offer a non-invasive way to assess carotenoid levels in the eye, skin, and blood. Unlike traditional methods that might require more invasive procedures, this approach could provide a quicker and more comfortable experience for patients. By accurately measuring carotenoid levels, scientists hope to better understand the role these nutrients play in eye health, potentially leading to improved preventive strategies for conditions like age-related macular degeneration. This could pave the way for personalized nutrition plans aimed at optimizing eye health.

What evidence suggests that carotenoid measurements are effective for understanding macular pigmentation?

Research has shown that carotenoids, such as lutein and zeaxanthin, benefit eye health. Studies have found that these nutrients can boost macular pigment levels, helping maintain clear vision. Evidence suggests that these supplements can enhance visual acuity and may slow the progression of eye diseases like age-related macular degeneration (AMD). Specifically, one study found that lutein and zeaxanthin reduced the risk of developing late-stage AMD. Regular intake of these nutrients also supports eye health for individuals who frequently use electronic devices. This trial will measure carotenoid levels in the eye, skin, and/or blood to further understand their impact on macular pigmentation. ^{1 3 6 7 8}

Who Is on the Research Team?

Paul Bernstein, MD

Principal Investigator

University of Utah Moran Eye Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

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Lutein, Zeaxanthin, and meso-Zeaxanthin in the Clinical ... Randomized, placebo-controlled clinical trials have demonstrated that xanthophyll supplementation increases macular pigment levels, improves visual function, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322005038

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 ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1522302/full

The effects of lutein/ zeaxanthin (Lute-gen®) on eye health ... The results from this study provide support for the beneficial effects of 6 months of lutein and zeaxanthin supplementation on regular users of electronic ...

4. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2792855

Long-term Outcomes of Adding Lutein/Zeaxanthin and ω-3 ... Lutein/zeaxanthin was associated with a reduction in the risk of progression to late AMD when compared with beta carotene.

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Lutein and Zeaxanthin and Their Roles in Age-Related ... It has been shown that supportive therapy with lutein and zeaxanthin can have a beneficial effect in delaying the progression of eye diseases ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2840187/

The Value of Measurement of Macular Carotenoid Pigment ... Results indicated that individuals with the highest blood levels and highest dietary intake of lutein and zeaxanthin had a 57% risk reduction for AMD (Seddon et ...

7. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00073-3/fulltext

Ocular Effects of Prenatal Carotenoid Supplementation in ... As exploratory endpoints, infants in the Carotenoid Group had a 20% increase in macular pigment optical density (P = 0.242) and more mature foveal parameters ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S240545772300133X

Fluorescence lifetime imaging ophthalmoscopy and the ... The antioxidant properties have led to the hypothesis that carotenoids may have a protective role against the development and progression of age-related macular ...