Impact of Lutein, Zeaxanthin, and Fish Oil on Health
The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
This study is testing if taking a daily supplement of lutein, zeaxanthin, and fish oil can help improve brain function, eye health, and bone strength in healthy adults aged 18-45 who have low eye pigment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Texas A&M University Academic / other |
| Locations | 1 site (College Station, Texas) |
| Trial ID | NCT06489873 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of lutein, zeaxanthin, and fish oil (LZF) supplementation on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults aged 18-45 with low MPOD. Participants will be randomly assigned to receive either the LZF supplement or a placebo daily for six months. The study aims to determine if LZF supplementation can significantly improve MPOD, cognitive performance, and bone density compared to controls. Assessments will include blood draws, MPOD measurements, DXA scans for bone health, and cognitive performance tests using Neurotracker software.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-45 with a macular pigment optical density (MPOD) of less than 0.43.
Not a fit: Patients with allergies to lutein, zeaxanthin, or fish oil, or those with certain eye conditions or on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function, enhanced visual health, and increased bone density in participants.
How similar studies have performed: Previous studies have shown promising results with similar supplementation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
College Station, Texas
- Gilchrist Building — College Station, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Karen M Beathard, PhD — Texas A&M University
- Study coordinator: Karen M Beathard, PhD
- Email: karen-beathard@tamu.edu
- Phone: 979-220-2281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.