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NCT Number: NCT06489873

Lutein, Zeaxathin, and Fish Oil Supplementation

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD <.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.

Healthy adults ages 18-45 years with MPOD <.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.

Exclusion criteria

  • allergic to lutein, zeaxanthin, or fish oil, taking supplements with >6 mg lutein and/or >2 mg zeaxanthin for more than two months before study starts, MPOD between >.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.

Treatment and study plan

Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)

Dietary Supplement

Each participant will be assigned to t a LZF supplement daily for six months

Placebo Comparator

Dietary Supplement

Each participant will be assigned to take a placebo supplement daily for six months

Primary outcomes

  1. Macular Pigment Optical Density (MPOD)

    Time frame: MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.

    The MPS II will be used to measure MPOD

  2. Cognitive Performance

    Time frame: Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study

    Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold.

  3. Bone Density

    Time frame: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.

    The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.

Secondary outcomes

  1. Lutein and Zeaxanthin Serum Levels

    Time frame: Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.

    Serum will be drawn and analyzed for lutein and zeaxanthin content

Study contacts

Contact information is provided by the study sponsor or research team.

Karen M Beathard, PhD

CONTACT

[email protected]

979-220-2281

Steven E Riechman, PhD

CONTACT

[email protected]

979-862-3213

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Allen Foundation Inc.

Registry information

Official study title

The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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