Age-Related Macular Degeneration, Bone Loss, Cognitive Performance
Conditions
Keywords
Lutein, Zeaxanthin, Fish Oil, Supplement, Macular Pigment, Macular Pigment Optical Density, Cognition, Age-related Macular Degeneration, Cognitive Performance
Brief summary
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.
Detailed description
Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD \<.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation. Healthy adults ages 18-45 years with MPOD \<.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.
Interventions
DIETARY_SUPPLEMENTActive Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
Each participant will be assigned to t a LZF supplement daily for six months
DIETARY_SUPPLEMENTPlacebo Comparator
Each participant will be assigned to take a placebo supplement daily for six months
Sponsors
Allen Foundation Inc.
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
A researcher not participating in the research randomized participants and packaged LZF and placebo supplements in the exact same bottle other than the participant number and delivered these to the PI for distribution. Only this person has the list of numbers associated with the supplements.
Intervention model description
Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Pigment Optical Density (MPOD) | 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. | The MPS II will be used to measure MPOD |
| Cognitive Performance | 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 | 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. |
| Bone Density | Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study. | The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lutein and Zeaxanthin Serum Levels | Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study. | Serum will be drawn and analyzed for lutein and zeaxanthin content |
Countries
United States
Contacts
Primary ContactKaren M Beathard, PhD
Backup ContactSteven E Riechman, PhD
Outcome results
None listed