NCT06489873

Lutein, Zeaxathin, and Fish Oil Supplementation

The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Performance
• Age-Related Macular Degeneration
• Bone Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)	Each participant will be assigned to t a LZF supplement daily for six months
DIETARY_SUPPLEMENT	Placebo Comparator	Each participant will be assigned to take a placebo supplement daily for six months

Timeline

• Start date: 2024-02-07
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-08
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States