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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults. The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months? Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation. Consuming a LZFO supplement for 6-months will improve visual cognitive performance. 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.

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.

What evidence supports the effectiveness of the treatment Lutein, Zeaxanthin, and Fish Oil Supplement for cognitive functioning?

Research shows that taking lutein and zeaxanthin can improve cognitive functions like attention and memory in older adults. Additionally, combining these with fish oil (which contains beneficial fatty acids) may further support brain health, especially in those with cognitive decline. ^{1 2 3 4 5}

Is the combination of Lutein, Zeaxanthin, and Fish Oil safe for humans?

Research on Lutein and Zeaxanthin supplements shows they are generally safe for humans, as they are naturally occurring nutrients found in the brain and have been studied for their positive effects on cognitive function in both older and younger adults. ^{1 2 6 7 8}

How does the Lutein, Zeaxanthin, and Fish Oil Supplement treatment differ from other treatments for cognitive functioning?

This treatment is unique because it combines lutein and zeaxanthin, which are carotenoids that accumulate in the brain and have been linked to improved cognitive function, with fish oil, known for its omega-3 fatty acids that support brain health. Unlike other treatments, this combination targets cognitive function through both antioxidant properties and support for brain cell membranes. ^{1 2 3 6 7}

Research Team

Karen M Beathard, PhD

Principal Investigator

Texas A&M University

Eligibility Criteria

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

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

MPOD less than .43

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Switzerland 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. [2020]

2. Switzerland 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. [2018]

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

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

4. Switzerland 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. [2023]

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

Effect of macular pigment carotenoids on cognitive functions: A systematic review. [2022]

6. Switzerland 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. [2022]

7. United States 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. [2022]

8. Switzerland 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. [2022]