50 Participants Needed

Carotenoid Supplementation for Retinal Health in Healthy Subjects

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Overseen ByAditi Deshpande
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how carotenoid supplements might support eye health, with a focus on the retina. Researchers aim to determine if these supplements can improve retinal thickness and visual abilities, such as contrast sensitivity and vision recovery after exposure to bright lights. The study also examines the relationship between carotenoid levels in the skin and eyes and investigates the supplements' potential effects on memory. Ideal participants have excellent vision (20/20 or better) in one eye and no history of eye or systemic diseases.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance eye health and cognitive function.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that interact with fat-soluble vitamins or carotenoids, like orlistat or certain antidiabetic drugs.

Is there any evidence suggesting that this carotenoid supplement is safe for humans?

Research shows that carotenoid supplements, such as lutein, are generally safe for use. Lutein, naturally found in the eye, helps protect it from light damage. Studies on another carotenoid, beta-carotene, have shown mixed results. Specifically, beta-carotene increased lung cancer risk in smokers, but this risk does not associate with lutein or other carotenoids used for eye health.

Most research suggests that carotenoids are well-tolerated, especially in normal dietary amounts. However, following dosage recommendations is important, as excessive intake can sometimes cause problems. For those considering joining a study, it is reassuring to know that carotenoids have a history of safe use. Always consult a doctor if there are any concerns.12345

Why are researchers excited about this trial?

Researchers are excited about carotenoid supplementation for retinal health because carotenoids are natural pigments found in fruits and vegetables, known for their powerful antioxidant properties. Unlike standard treatments that may focus on pharmaceuticals or surgical interventions, carotenoids like lutein and zeaxanthin aim to protect retinal cells by neutralizing harmful free radicals. This natural approach could offer a preventative measure to maintain retinal health, potentially reducing the risk of degenerative eye conditions without the side effects associated with more invasive treatments.

What evidence suggests that carotenoid supplementation could be effective for retinal health?

Research shows that carotenoid supplements, which participants in this trial may receive, can help maintain eye health. Studies have found that taking 24 mg of these supplements daily significantly increases the density of protective pigments in the eye, shielding them effectively. These supplements are also linked to better sleep and reduced eye strain. Carotenoids, nutrients found in plants, might reduce the risk of age-related macular degeneration (AMD), a condition that can harm vision with age. Specifically, people with low intake of lutein and zeaxanthin, two types of carotenoids, had a 26% lower risk of advanced AMD. This suggests that carotenoid supplements could be a valuable addition to support eye health.16789

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-75 with good vision (20/20 or better), normal eye pressure, internet access, and the ability to consent. It's not suitable for those who don't meet these specific visual and health criteria.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.
I have access to the Internet.
My vision in one eye is 20/20 or better with correction.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants receive either a carotenoid supplement or placebo daily for 3 months

3 months
1 visit (in-person) at the start, 2 follow-up visits (in-person) at 1 month and 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person) at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carotenoid Supplement

Trial Overview

The study tests if carotenoid supplements can improve retinal health in healthy adults. It measures changes in macular pigment density, retinal thickness, blood vessel density, ocular perfusion pressure, contrast sensitivity, photostress recovery time, skin carotenoid levels and cognitive function over three visits within three months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment- Carotenoid SupplementationExperimental Treatment1 Intervention
Group II: PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pacific University

Lead Sponsor

Trials
14
Recruited
1,100+

MacuHealth

Industry Sponsor

Trials
2
Recruited
40+

Citations

Macular Carotenoid Supplementation Improves Visual ...

MC supplementation (24 mg daily) yielded significant improvement in MPOD, overall sleep quality, headache frequency, eye strain, eye fatigue, ...

Carotenoid Supplementation and Retinal Health in Healthy ...

Our goal is to investigate the protective role of this oral carotenoid supplement on the macular structure, measured as retinal thickness, ...

Benefits of plant carotenoids against age-related macular ...

Plant carotenoids reduce AMD based on in vitro, in vivo and clinical trials. Carotenoid benefits determined by treatment duration, body weight and exposure.

Long-term Outcomes of Adding Lutein/Zeaxanthin and ω-3 ...

This epidemiologic follow-up study investigates the long-term findings of the Age-Related Macular Degeneration Study 2 (AREDS2) trial ...

Vitamin A and Carotenoids - Health Professional Fact Sheet

In a more detailed analysis, participants with the lowest dietary intakes of lutein and zeaxanthin had a 26% lower risk of advanced AMD when ...

Carotenoid Supplementation and Retinal Health in Healthy ...

Our goal is to investigate the protective role of this oral carotenoid supplement on the macular structure, measured as retinal thickness, ...

Lutein - Uses, Side Effects, and More

Lutein is one of two major carotenoids found in the human eye (macula and retina). It is thought to function as a light filter, protecting the eye tissues from ...

The Benefits and Risks of Certain Dietary Carotenoids that ...

Later studies found that β-carotene supplementation exacerbated UV-carcinogenic expression. The discrepancies of these results were related to the type of diet ...

Effect of Antioxidant Supplementation on Macular Pigment ...

This review showed that various combinations of antioxidants would have distinct effects on improving visual health from multiple angles.