Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06489873

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

Led by Texas A&M University · Updated on 2025-09-30

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Texas A&M University

Lead Sponsor

A

Allen Foundation Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of lutein, zeaxanthin, and fish oil (LZF) supplements on healthy adults aged 18 to 45 who have low macular pigment optical density (MPOD). The trial aims to find out if taking LZF for six months can improve MPOD, cognitive performance, and bone density compared to a placebo. The study uses a precision nutrition model to address risks related to aging, including macular degeneration, cognitive decline, and bone loss. Participants will be randomly assigned to take either a daily LZF supplement containing 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo supplement. This treatment lasts for six months. The study is double-blind and controlled, meaning neither participants nor researchers know who receives the supplement or placebo. During the trial, participants will undergo assessments at the start, three months, and six months. These include measuring MPOD, cognitive performance using Neurotracker software, bone density via DXA scans, fasting blood samples, and serum levels of lutein and zeaxanthin. Researchers will track changes over time to understand the impact of the supplements on vision, thinking skills, and bone health.

CONDITIONS

Brief Title

Lutein, Zeaxathin, and Fish Oil Supplementation

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 45 years
  • Macular pigment optical density (MPOD) less than 0.43
  • Self-reported best-corrected vision of 20/40 or better in each eye
  • Body mass index (BMI) between 18.5 and 30
  • Meets inclusion criteria on the preliminary participant questionnaire
Not Eligible

You will not qualify if you...

  • Allergy to lutein, zeaxanthin, or fish oil
  • Taking supplements with more than 6 mg lutein or more than 2 mg zeaxanthin for over two months before study start
  • MPOD greater than 0.43
  • Self-reported 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 diet (due to gelatin in placebo)
  • Taking neuroactive medications such as Ritalin, Adderall, or antidepressants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to assess eligibility including macular pigment optical density (MPOD) and other criteria

Treatment

Duration - 6 months

Participants take a daily supplement of lutein, zeaxanthin, and fish oil or a placebo for six months.

Visits at baseline, 3 months, and 6 months with multiple assessments including blood draws, MPOD, bone density, and cognitive performance

Trial Site Locations

Total: 1 location

1

Gilchrist Building

College Station, Texas, United States, 77843

Actively Recruiting

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Research Team

K

Karen M Beathard, PhD

S

Steven E Riechman, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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