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Dietary Supplement

Lutein, Zeaxanthin, and Fish Oil for Cognitive Functioning

N/A
Recruiting
Led By Karen M Beathard, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Autoimmune disorders related to visual health
History of concussion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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

Summary

This trial aims to study the effects of a supplement containing lutein, zeaxanthin, and fish oil (LZF) on healthy adults. They want to see if taking this supplement for

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Potential side effects are not detailed here; however, common side effects from such supplements may include stomach upset or fishy aftertaste. Since these are naturally occurring nutrients at presumably safe levels, severe side effects might be rare.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disorder affecting my eyes.
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I have had a concussion before.
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I have been taking supplements with more than 6 mg of lutein or more than 2 mg of zeaxanthin for over two months.
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I experience vertigo.
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I have been diagnosed with optic neuropathy.
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I have diabetic retinopathy.
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I have been diagnosed with retinitis pigmentosa.
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I have crossed eyes.
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I have had blockages in the blood vessels of my eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone Density
Cognitive Performance
Macular Pigment Optical Density (MPOD)
Secondary study objectives
Lutein and Zeaxanthin Serum Levels

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LZF SupplementActive Control1 Intervention
Participants will take one LZF supplement daily for six months.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take on placebo supplement daily for six months.

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
147 Previous Clinical Trials
23,783 Total Patients Enrolled
Allen Foundation Inc.OTHER
3 Previous Clinical Trials
422 Total Patients Enrolled
Karen M Beathard, PhDPrincipal InvestigatorTexas A&M University
~29 spots leftby May 2025