Lutein, Zeaxathin, and Fish Oil Supplementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorTexas A&M University
About this trial
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
Qualifiers
<.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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
- Placebo Comparator
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Texas A&M University
Lead sponsor
Allen Foundation Inc.
Collaborator
Source ClinicalTrials.gov