Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489873
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Lutein Zeaxathin and Fish Oil Supplementation
Sponsor:
Texas AM University
Organization:
Texas AM University
Study Overview
Official Title:
The Role of Lutein Zeaxanthin and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None