Lutein, Zeaxathin, and Fish Oil Supplementation

Last updated: September 24, 2025
Sponsor: Texas A&M University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Osteoporosis

Myopic Macular Degeneration

Treatment

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

Placebo Comparator

Clinical Study ID

NCT06489873
2024-0035
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
May 01, 2026

Study Description

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.

Connect with a study center

  • Gilchrist Building

    College Station, Texas 77843
    United States

    Site Not Available

  • Gilchrist Building

    College Station 4682464, Texas 4736286 77843
    United States

    Active - Recruiting

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