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| Name | Class |
|---|---|
| Allen Foundation Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LZF Supplement | Active Comparator | Participants will take one LZF supplement daily for six months. |
|
| Placebo | Placebo Comparator | Participants will take on placebo supplement daily for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF) | Dietary Supplement | Each participant will be assigned to t a LZF supplement daily for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular Pigment Optical Density (MPOD) | The MPS II will be used to measure 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. |
| 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. | 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 |
| Bone Density | The Horizonâ„¢ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep. | Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Lutein and Zeaxanthin Serum Levels | Serum will be drawn and analyzed for lutein and zeaxanthin content | Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen M Beathard, PhD | Contact | 979-220-2281 | karen-beathard@tamu.edu | |
| Steven E Riechman, PhD | Contact | 979-862-3213 | sriechman@tamu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen M Beathard, PhD | Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilchrist Building | Recruiting | College Station | Texas | 77843 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.
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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.
| Placebo Comparator | Dietary Supplement | Each participant will be assigned to take a placebo supplement daily for six months |
|
| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |