Gilchrist Building
College Station, Texas, 77843, United States
Location status: Recruiting
Location contact
Karen M. Beathard, PhD
CONTACT
Steven E. Riechman, PhD
CONTACT
NCT Number: NCT06489873
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
College Station, Texas, 77843, United States
Location status: Recruiting
Karen M. Beathard, PhD
CONTACT
Steven E. Riechman, PhD
CONTACT
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 volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will be assigned to t a LZF supplement daily for six months
Each participant will be assigned to take a placebo supplement daily for six months
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.
The MPS II will be used to measure MPOD
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 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.
Time frame: 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.
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.
Serum will be drawn and analyzed for lutein and zeaxanthin content
Contact information is provided by the study sponsor or research team.
Karen M Beathard, PhD
CONTACT
Steven E Riechman, PhD
CONTACT
Texas A&M University
Other
The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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