Carotenoids for Eye Health

(EyeCARE Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: Hypertension, Diabetes, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a daily carotenoid supplement taken for four months can improve eye health and reduce visual fatigue. It will also assess whether the supplement affects brain function. Researchers will divide participants into two groups: one taking the carotenoid supplement and the other taking a placebo (a pill with no active ingredients). The trial seeks adults aged 20-45 with clear vision and no major health issues, such as diabetes or heart disease. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on eye and brain health.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carotenoid supplements, like the one used in this trial, are usually well-tolerated. Lutein, a main ingredient in the supplement, is often called "the eye vitamin" because it supports eye health. Other ingredients, such as maqui berry and bilberry extract, are rich in antioxidants, which help reduce eye strain and protect the eyes from damage. Studies indicate that these ingredients can alleviate eye strain and dry eyes without altering the eye's structure.

Overall, there are no major reports of serious side effects from carotenoid supplements. Most people experience no issues when taking them. This evidence suggests that the treatment is likely safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Carotenoid Complex Supplement because it combines several powerful antioxidants like lutein, zeaxanthin, and astaxanthin, which are not typically found together in standard eye health treatments. Unlike traditional options that may focus on a single ingredient, this supplement offers a comprehensive approach by also including maqui berry and bilberry extracts, known for their potential to support vision. Additionally, the inclusion of flaxseed oil and vitamin E in the formulation aims to enhance the absorption and effectiveness of these nutrients, potentially offering a more holistic benefit for eye health.

What evidence suggests that this trial's treatments could be effective for eye health?

Research has shown that carotenoids, especially lutein and zeaxanthin, are linked to better eye health and a lower risk of eye problems. One study found that a mix of plant-based ingredients, including carotenoids, reduced eye fatigue and dry eye symptoms. Combining carotenoids with other nutrients like anthocyanins (natural plant colors) may lessen eye strain, particularly from screens. Astaxanthin, another carotenoid, has also been studied and shown to support eye health. In this trial, participants in the Carotenoid Complex Supplement arm will receive a supplement containing these ingredients. These findings suggest that the carotenoid complex supplement could effectively reduce visual fatigue and improve overall eye health. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

The EyeCARE trial is for adults aged 20-45 who are interested in the potential effects of carotenoids on eye health and visual fatigue. Participants should not have any existing conditions that could interfere with the study's outcomes.

Inclusion Criteria

I do not have diabetes.

I am between 20 and 45 years old.

20/20 or corrected vision

Exclusion Criteria

Not 20/20 or uncorrected vision

I am either under 20 or over 45 years old.

MPOD greater than 0.60

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily carotenoid complex supplementation for 4 months

16 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carotenoid Group
• Control (placebo) group

Trial Overview This study tests if taking a carotenoid supplement daily for four months can change levels in the macula (part of the eye) and skin, and improve visual fatigue. It also looks at how it might affect cognitive function.

How Is the Trial Designed?

Group I: Carotenoid Complex Supplement Experimental Treatment 1 Intervention

20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel)

Group II: Control Placebo Group 1 Intervention

flaxseed oil (330mg)

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Daiken Biomedical Co., Ltd.

Collaborator

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6390265/

Health Benefits of Polyphenols and Carotenoids in Age ... This review deals in depth with the role of antioxidant polyphenol and carotenoid properties in the prevention and treatment of age-related ophthalmic diseases, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522008036

A novel botanical formula improves eye fatigue and dry eye Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective ...

3. mdpi.com mdpi.com/2072-6643/14/19/4005

Can Nutrition Play a Role in Ameliorating Digital Eye Strain? Traditionally, carotenoids by themselves did not appear to alleviate dry eye or signs of ocular fatigue so they were often combined with anthocyanins and other ...

4. lifeextension.com lifeextension.com/protocols/eye-ear/eye-health?srsltid=AfmBOoqASDsUVzgiDl_JqKSbTCs9ErxOeZbclmoI-alKYDGq00HcLjY4

Eye Health Carotenoids: Higher carotenoid consumption, especially lutein, zeaxanthin, and meso-zeaxanthin, has been linked to better eye health, including a lower risk ...

5. naturalpractitionermag.com naturalpractitionermag.com/seeing-is-believing/

Seeing is Believing * Astaxanthin is another carotenoid that has been widely studied to support eye health.* In preclinical and clinical studies, it has been ...

6. amazon.com amazon.com/Livingood-Daily-Lutein-Zeaxanthin-Supplements-Eye-Vitamins/dp/B0BC2CVG79

Livingood Daily Eye Support, 13-in-1 Vision Supplement ... Maqui Berry. Contains high levels of antioxidants that have been shown to support eye health. · Lycopene. Helps support the eyes from free radicals to support ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-754/lutein

Lutein - Uses, Side Effects, and More Lutein is a type of organic pigment called a carotenoid. It is related to beta-carotene and vitamin A. Many people think of lutein as "the eye vitamin."

8. lifeextension.com lifeextension.com/protocols/eye-ear/eye-health?srsltid=AfmBOoowTDSlIbi7DHZorGjCnCyaAfew7qwAtQj2FyMxK3cbgFsRMa5C

Eye Health Nutrient interventions such as omega-3 fatty acids, carotenoids, and B-complex vitamins have been shown to support eye health during aging.