Lutein, Zeaxanthin, and Fish Oil for Cognitive Functioning

Overseen By Steven E Riechman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Must not be taking: Neuroactive medications

Disqualifiers: Pregnancy, Vegan, Autoimmune disorders, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement containing lutein, zeaxanthin, and fish oil (LZF) can enhance brain function, improve vision, and strengthen bones in healthy adults. Participants will take either the LZF supplement or a placebo daily for six months. This trial suits individuals with below-average macular pigment (an eye health marker) and good vision (20/40 or better) who have no allergies to the ingredients. As an unphased trial, it provides a unique opportunity to contribute to scientific understanding and potentially benefit from the supplement's effects.

Will I have to stop taking my current medications?

The trial requires that you do not take neuroactive medications, such as Ritalin, Adderall, or antidepressants, to participate. If you are on these medications, you would need to stop taking them to join the trial.

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

Research shows that lutein, zeaxanthin, and fish oil are generally safe and easy to tolerate. One study with healthy older adults found that supplements containing these ingredients did not cause significant side effects. Participants took a similar supplement for several months and reported good tolerance.

Other studies have found that lutein and zeaxanthin can improve vision and thinking skills without causing serious side effects. These nutrients are often included in supplements to support eye and brain health. Fish oil, which contains omega-3 fatty acids, is also commonly used for heart and brain health and is generally safe for most people.

Overall, research suggests that the supplements used in this trial are likely safe for people, based on past studies with similar ingredients. However, consulting a healthcare provider about any concerns before starting new supplements is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cognitive decline rely on pharmaceuticals targeting neurotransmitters. But this new approach uses natural supplements—lutein, zeaxanthin, and fish oil—which are known for their antioxidant and anti-inflammatory properties. Researchers are excited because these ingredients may support brain health by reducing oxidative stress and inflammation, potentially offering a safer alternative with fewer side effects. Unlike conventional drugs, these supplements are derived from everyday nutrients that are already part of a healthy diet, making them an attractive option for long-term use.

What evidence suggests that LZF supplementation could be effective for improving cognitive performance, MPOD, and bone density?

This trial will compare the effects of a Lutein, Zeaxanthin, and Fish Oil (LZF) supplement with a placebo on cognitive functioning. Studies have shown that taking supplements like lutein, zeaxanthin, and fish oil for six months can improve certain mental skills, such as visual memory and learning new information. Research also suggests these supplements can enhance eye health by increasing macular pigment optical density (MPOD). Evidence indicates these supplements might also strengthen bones. However, one study found no significant effect on mental abilities in older adults with specific eye conditions. Overall, early findings suggest benefits for vision and brain health, but results can vary depending on the individual and their condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Karen M Beathard, PhD

Principal Investigator

Texas A&M University

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in whether taking supplements of lutein, zeaxanthin, and fish oil (LZF) can improve eye health, brain function, and bone density. Specific eligibility criteria are not provided but typically would include age range and general health status.

Inclusion Criteria

MPOD less than .43

Self-reported best-corrected vision of 20/40 or better in each eye

BMI range of 18.5-30

Exclusion Criteria

I have diabetic retinopathy.

Allergic to lutein, zeaxanthin, or fish oil

Currently pregnant or trying to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a LZF supplement or placebo daily for 6 months

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

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 Fish Oil Supplement

Trial Overview The study tests if daily LZF supplementation over six months enhances macular pigment optical density (important for eye health), cognitive performance, and bone mass compared to a placebo (a substance with no active therapeutic effect).

How Is the Trial Designed?

Group I: LZF Supplement Active Control 1 Intervention

Participants will take one LZF supplement daily for six months.

Group II: Placebo Placebo Group 1 Intervention

Participants will take on placebo supplement daily for six months.

Lutein, Zeaxanthin, and Fish Oil Supplement is already approved in United States, European Union for the following indications:

Approved in United States as Lutein/Zeaxanthin/Omega-3 Supplement for:

• Dietary Supplement for Eye Health
• Supports Macular Health

Approved in European Union as Lutein/Zeaxanthin/Omega-3 Supplement for:

• Food Supplement for Eye Health
• Contributes to Normal Vision

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Allen Foundation Inc.

Collaborator

Trials

4

Recruited

500+

Published Research Related to This Trial

A year-long study with 51 young, healthy adults showed that daily supplementation with lutein and zeaxanthin significantly increased macular pigment optical density (MPOD), indicating improved levels of these nutrients in the central nervous system.

The supplementation also led to notable improvements in cognitive functions such as spatial memory, reasoning ability, and complex attention, suggesting that L + Z can enhance cognitive performance in younger adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Lutein and Zeaxanthin Intervention on Cognitive Function: A Randomized, Double-Masked, Placebo-Controlled Trial of Younger Healthy Adults. Renzi-Hammond, LM., Bovier, ER., Fletcher, LM., et al.[2018]

Lutein and zeaxanthin, carotenoids that accumulate in the brain and form macular pigment in the eye, are correlated with cognitive health, particularly in older adults, suggesting they may serve as biomarkers for brain health.

A 4-month clinical trial showed that lutein supplementation improved verbal fluency and memory in older women, especially when combined with DHA, indicating potential cognitive benefits of these nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A possible role for lutein and zeaxanthin in cognitive function in the elderly. Johnson, EJ.[2023]

A 6-month study involving 90 adults aged 40-75 showed that supplementation with lutein and zeaxanthin significantly improved visual episodic memory and visual learning compared to a placebo.

The supplementation was well-tolerated with no significant adverse effects reported, but it did not show improvements in other cognitive tests or self-reported measures of cognition and mood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Lutein and Zeaxanthin Supplementation on Cognitive Function in Adults With Self-Reported Mild Cognitive Complaints: A Randomized, Double-Blind, Placebo-Controlled Study. Lopresti, AL., Smith, SJ., Drummond, PD.[2022]

In a study of older adults (60 years and over) using data from the NHANES 2011-2014, higher dietary intake of lutein and zeaxanthin was associated with better cognitive function, as measured by various cognitive tests.

The risk of non-alcoholic fatty liver disease (NAFLD) was found to mediate this association, suggesting that managing liver health may be important for optimizing cognitive function in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediation Role of the Risk of Non-Alcoholic Fatty Liver Disease in Relationship between Lutein and Zeaxanthin and Cognitive Functions among Older Adults in the United States. Chen, C., Lu, Z., Zhang, D., et al.[2022]

In a study involving healthy older Japanese individuals, supplementation with a combination of long-chain polyunsaturated fatty acids (LCPUFAs) and carotenoids (lutein and zeaxanthin) for up to 24 weeks did not significantly improve memory function in those without cognitive decline.

However, the same supplementation showed beneficial effects on memory function in older individuals who exhibited cognitive decline, suggesting that this combination may be more effective for those already experiencing memory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Long-Chain Polyunsaturated Fatty Acids in Combination with Lutein and Zeaxanthin on Episodic Memory in Healthy Older Adults. Sueyasu, T., Yasumoto, K., Tokuda, H., et al.[2023]

In a study of 54 older adults, higher levels of lutein and zeaxanthin in the retina and blood were linked to better white matter integrity in specific brain regions, suggesting these nutrients may help maintain brain health as we age.

The research used advanced imaging techniques to show that lutein and zeaxanthin positively affect brain structure, particularly in areas that are prone to decline with age, highlighting the potential benefits of dietary intake of these phytonutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of Retinal and Serum Lutein and Zeaxanthin to White Matter Integrity in Older Adults: A Diffusion Tensor Imaging Study. Mewborn, CM., Terry, DP., Renzi-Hammond, LM., et al.[2022]

This systematic review of 19 studies, including 7 randomized controlled trials, found a significant relationship between macular pigment optical density (MPOD) and cognitive functions, particularly in memory, processing speed, attention, and reasoning.

Increasing dietary intake of lutein and zeaxanthin through supplements or foods like avocados was shown to enhance MPOD levels and improve cognitive performance in most trials, suggesting these carotenoids may play a beneficial role in brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of macular pigment carotenoids on cognitive functions: A systematic review. García-Romera, MC., Silva-Viguera, MC., López-Izquierdo, I., et al.[2022]

In a double-masked, randomized, placebo-controlled trial involving 62 older adults, supplementation with lutein and zeaxanthin (L+Z) significantly increased retinal levels of these carotenoids and improved cognitive functions such as complex attention and cognitive flexibility.

The study found that while both men and women benefited from L+Z supplementation, male participants specifically showed significant improvements in composite memory, highlighting the potential of L+Z as a cognitive enhancer in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Lutein/Zeaxanthin Supplementation on the Cognitive Function of Community Dwelling Older Adults: A Randomized, Double-Masked, Placebo-Controlled Trial. Hammond, BR., Miller, LS., Bello, MO., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06489873?term=AREA%5BConditionSearch%5D(Fish%20eye%20disease%20OR%20%22fed%22%20OR%20%22%20partial%20LCAT%20deficiency%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=3

Lutein, Zeaxathin, and Fish Oil Supplementation Consuming a LZFO supplement for 6-months will improve bone density. Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8891800/

The Effects of Lutein and Zeaxanthin Supplementation on ... The results from this trial suggest that 6-months of supplementation with lutein and zeaxanthin may improve visual memory and learning in community-dwelling ...

3. trialx.com trialx.com/clinical-trials/listings/305587/lutein-zeaxathin-and-fish-oil-supplementation/

Lutein, Zeaxathin, and Fish Oil Supplementation - Bone Loss Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve ...

4. withpower.com withpower.com/trial/phase-cognitive-performance-1-2024-e150f

Lutein, Zeaxanthin, and Fish Oil for Cognitive Functioning 43 will significantly improve MPOD after 6-months of LZF supplementation.Consuming a LZFO supplement for 6-months will improve visual cognitive performance.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2429713

Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other ... Among older persons with AMD, oral supplementation with LCPUFAs or lutein/zeaxanthin had no statistically significant effect on cognitive function.

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Lutein_and_zeaxanthin_%28supplement%29.pdf

Lutein and Zeaxanthin A 2022 study randomized 60 healthy older adults to receive either placebo or a combination supplement of omega-3 fatty acids, vitamin E, lutein (10 mg), ...

7. amazon.com amazon.com/Longevity-Health-Lutein-Zeaxanthin-Servings/dp/B07BDQZPJ7

Omega 3 Supplement for Brain, Heart & Eye Health – 460 ... Our Brain Omega supplement provides all three DHA, EPA, lutein, and zeaxanthin to support brain and eye health. High Potency in Every Softgel: Each serving of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960892/

Lutein and Zeaxanthin Supplementation Improves Dynamic ... Supplementation with dietary neuro-pigments lutein (L) and zeaxanthin (Z) has been shown to improve many aspects of visual and cognitive function in adults.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2475299122130404

Lutein across the Lifespan: From Childhood Cognitive ... In this study, supplementation with lutein, zeaxanthin, and omega-3 fatty acids, including DHA, for 4 mo increased MP and improved neural processing speed.