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
This trial accepts healthy volunteersQualifiers
<.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
Design model
Parallel
Treatments tested in this trial
Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
Dietary supplementEach participant will be assigned to t a LZF supplement daily for six months
Placebo Comparator
Dietary supplementEach participant will be assigned to take a placebo supplement daily for six months
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: LZF SupplementActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Macular Pigment Optical Density (MPOD)
The MPS II will be used to measure MPOD
Time frame
MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.2
Cognitive Performance
Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold.
Time frame
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 study3
Bone Density
The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.
Time frame
Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.Secondary outcomes
1
Lutein and Zeaxanthin Serum Levels
Serum will be drawn and analyzed for lutein and zeaxanthin content
Time frame
Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas A&M University
Lead sponsor
Allen Foundation Inc.
Collaborator
Source ClinicalTrials.gov