Recruiting

Lutein, Zeaxanthin, Fish Oil

Sponsor:

Texas A&M University

Code:

NCT06489873

Conditions

Cognitive Performance

Age-Related Macular Degeneration

Bone Loss

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

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

Placebo Comparator

Study Details

Brief summary:

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.

Conditions

Cognitive Performance

Age-Related Macular Degeneration

Bone Loss

Study ID

NCT06489873

Start date

Feb 7, 2024

Status verified date

Sep, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: LZF Supplement

Participants will take one LZF supplement daily for six months.

placebo comparator: Placebo

Participants will take on placebo supplement daily for six months.

Interventions

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

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

Placebo Comparator

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

Primary outcome measure

  • 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. ]
  • 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 ]
  • 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. ]

Central Contacts and Locations

Central contacts

Karen M Beathard, PhD

979-220-2281karen-beathard@tamu.edu

Steven E Riechman, PhD

979-862-3213sriechman@tamu.edu

Locations

Gilchrist Building

Recruiting

College Station, Texas, United States, 77843

Contacts

Steven E. Riechman, PhD

979-862-3213sriechman@tamu.edu

Karen M. Beathard, PhD

979-220-2281karen-beathard@tamu.edu

More Information

Sponsor

Texas A&M University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • Lutein
  • Zeaxanthin
  • Fish Oil
  • Supplement
  • Macular Pigment
  • Macular Pigment Optical Density
  • Cognition
  • Age-related Macular Degeneration
  • Cognitive Performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.